M.tech. Pharma Bio

ANNA UNIVERSITY: CHENNAI 600 025
NON AUTONOMOUS COLLEGES AFFILIATED TO ANNA UNIVERSITY

REGULATIONS – 2021
M. TECH. PHARMACEUTICAL BIOTECHNOLOGY
CHOICE BASED CREDIT SYSTEM
I TO IV SEMESTERS CURRICULUM AND SYLLABUS
PROGRAM EDUCATIONAL OUTCOMES (PEOs)
PEO1: To provide our students with a rigorous postgraduate education that will enable them
to flourish in research and career in the field of pharmaceutical biotechnology.
PEO2: To give students a firm foundation in the principles of engineering, science, and
statistics required to address issues relating to biologicals and biopharmaceuticals.
PEO3: To equip the students with the necessary scientific and technological knowledge to
understand, evaluate, design and develop original solutions for health-related issues.
PEO4: To instill in pupils a sense of professional and scientific ethics, scientific
communication abilities, and collaboration abilities, a multidisciplinary strategy, and
the capacity to address health-related issues on a larger scale social setting.
Ten
PROGRAM OUTCOMES (POS)
PO1:
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Acquire in-depth knowledge of Pharmaceutical sciences, Biological sciences and
Bioengineering for gaining ability to develop innovative solutions and evaluate new
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ideas for societal benefits.
PO2: Facilitate the students to gain the wisdom of fundamentals and advances to practice
pharmaceutical biotechnology, interdisciplinary research and entrepreneurship as
career of constructive service to society and higher learning.
PO3: Articulate a degree of mastery over the area as per the specialization of the program.
PO4: Recognize the need for continuous learning and will prepare oneself to create, select,
learn and apply appropriate techniques, resources, and modern instrumentation to
solve complex biotechnological activities.
PO5: Possess scientific or technological knowledge in the domain of Pharmaceutical
Biotechnology and recognize opportunities to demonstrate a capacity for teamwork,
effective communication, decision-making based on open-mindedness and rational
analysis in order to achieve common goals.
PO6: Demonstrate knowledge of Pharmaceutical biotechnology and management
principles and apply to manage projects efficiently and economically with intellectual
integrity and ethics for sustainable development of society.
ANNA UNIVERSITY, CHENNAI
NON-AUTONOMOUS COLLEGES AFFILIATED TO ANNA UNIVERSITY
REGULATIONS 2021
M.TECH. PHARMACEUTICAL BIOTECHNOLOGY
CHOICE BASED CREDIT SYSTEM
I TO IV SEMESTERS (FULL TIME) CURRICULA
SEMESTER I
CREDITS
PERIODS TOTAL
S. COURSE CATE- PER WEEK CONTACT
COURSE TITLE
No. CODE GORY
PERIODS
L T P
THEORY
Analytical techniques in
1. Pharmaceutical PCC 3 0 0 3 3
Biotechnology
Pharmaceutical PCC
2. Microbiology 3 0 0 3 3
3.
4.
Ten
Industrial Fermentation
Research Methodology and
IPR
PCC
RMC
3
2
0
0
0
0
3
2
3
2
5.
6.
Drug Regulatory Affairs
Professional Elective I
tativ
PCC
PEC
3
3
0
0
0
0
3
3
3
3
7.
8.
PRACTICALS
9.
Professional Elective II
Audit Course*
Analytical techniques in
Pharmaceutical
Biotechnology Laboratory
PEC
AC
PCC
3
2
0
0
0
0
e
0
0
6
3
6
2
3
0
TOTAL 22 0 6 28 23
*Audit Course is Optional

SEMESTER II
PERIODS TOTAL CREDITS

S. COURSE CATE- PER WEEK
COURSE TITLE CONTACT
No. CODE GORY
L T P PERIODS
THEORY
Protein and Protein PCC
1. Formulations 3 0 0 3 3
2. Immunotechnology PCC 3 0 0 3 3
Techniques in Molecular PEC
3. Biology and Genetic 3 0 0 3 3
Engineering
4. Professional Elective III PEC 3 0 0 3 3
5. Professional Elective IV PEC 3 0 0 3 3
6. Open elective OEC 3 0 0 3 3
7. Audit Course II* AC 2 0 0 2 0
PRACTICALS
Immunotechnology PCC
8. 0 0 6 6 3
Laboratory
9.
Ten
Drug discovery
Laboratory
PCC
0 0 6 6 3
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TOTAL 20 0 12 32 24
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SEMESTER III
PERIODS CREDITS
TOTAL
No. CODE GORY
L T P PERIODS
PRACTICALS
Protein and Protein PCC
1. Formulations Laboratory 0 0 6 6 3
Bioinformatics and
2. computational biology PCC 0 0 6 6 3
laboratory
3. Project Work I EEC 0 0 12 12 6
4. Summer Internship*** EEC 0 0 0 0 2
TOTAL 0 0 24 24 14
SEMESTER IV
PERIODS TOTAL
No. CODE GORY CREDITS
L T P PERIODS
PRACTICALS
1. Project Work II EEC 0 0 24 24 12
TOTAL 0 0 24 24 12
TOTAL CREDITS: 73
SEMESTER I, ELECTIVES I
PERIODS CREDITS
TOTAL
No. CODE GORY
L T P PERIODS
THEORY
Ten
Nanobiotechnology PEC 3 0 0 3 3
1.
Thermodynamics for PEC 3 0 0 3 3
2.
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Biological Systems
Enzyme Engineering and PEC 3 0 0 3 3
3.
Technology
4.
S. COURSE
Metabolic Process and
Engineering
PEC
SEMESTER I, ELECTIVES II
PERIODS
CATE- PER WEEK
3 0
e0
TOTAL
3 3
CREDITS
No. CODE GORY
L T P PERIODS
THEORY
Applied PEC 3 0 0 3 3
1. Biopharmaceutics and
Pharmacokinetics
2. Molecular Medicine PEC 3 0 0 3 3
Biogenerics and PEC 3 0 0 3 3
3.
Biopharmaceuticals
Environmental PEC 3 0 0 3 3
4. Biotechnology
SEMESTER II, ELECTIVES III
PERIODS TOTAL CREDITS

No. CODE GORY
L T P PERIODS
THEORY
Bioinformatics and PEC 3 0 0 3 3
1. Computational Biology
Bioprocess Engineering PEC 3 0 0 3 3
2.
and Technology
3. Molecular Pharmacology PEC 3 0 0 3 3
Bioconjugate PEC 3 0 0 3 3
4.
Technology
SEMESTER II, ELECTIVES IV

PERIODS CREDITS
Ten
TOTAL
No. CODE GORY
L T P PERIODS
THEORY
1.
2.
Pharmacogenomics
Bio-entrepreneurshiptativ PEC
PEC
3
3
0
0
0
0
3
3
3
3
3.
4.
Biomaterials and Tissue
Engineering
Advances in Omics
Sciences and
Technology
PEC
PEC
3
3
0
0
e
0
0
3
3
3
PROFESSIONAL CORE (PCC)
PERIODS TOTAL
S. COURSE CATE PER WEEK
COURSE TITLE CONTACT CREDITS
NO. CODE GORY
L T P PERIODS
THEORY
1. Analytical techniques in
Pharmaceutical PCC 3 0 0 3 3
Biotechnology
2. Pharmaceutical PCC
3 0 0 3 3
Microbiology
3. Industrial Fermentation PCC 3 0 0 3 3
4. Drug Regulatory Affairs PCC 3 0 0 3 3
5. Protein and Protein PCC
3 0 0 3 3
Formulations
6. Immunotechnology PCC
3 0 0 3 3
7. Analytical techniques in PCC 0 0 6 3 3
Pharmaceutical
Biotechnology Laboratory
8. Immunotechnology PCC
0 6 6 3 3
Laboratory
9. Drug discovery PCC
0 6 6 3 3
Laboratory
10. Protein and Protein PCC
0 6 6 3 3
Formulations Laboratory
11. Bioinformatics and
computational biology PCC 0 6 6 3 3
laboratory
PROFESSIONAL ELECTIVE COURSES (PEC)
PERIODS PER TOTAL

S. COURSE CATE WEEK
NO. CODE GORY
L T P PERIODS
THEORY
1. Nanobiotechnology PEC 3 0 0 3 3
2.
3.
Ten
Thermodynamics for
Biological Systems
Enzyme Engineering and
PEC
PEC
3 0 0 3 3
tativ
3 0 0 3 3
Technology
4. Metabolic Process and PEC
3 0 0 3 3
Engineering
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5. Techniques in Molecular PEC
Biology and Genetic 3 0 0 3 3
Engineering
6. Applied Biopharmaceutics PEC
3 0 0 3 3
and Pharmacokinetics
7. Molecular Medicine PEC 3 0 0 3 3
8. Biogenerics and PEC
3 0 0 3 3
Biopharmaceuticals
9. Environmental PEC
3 0 0 3 3
Biotechnology
10. Bioinformatics and PEC
3 0 0 3 3
Computational Biology
11. Bioprocess Engineering PEC
3 0 0 3 3
and Technology
12. Molecular Pharmacology PEC 3 0 0 3 3
13. Bioconjugate Technology PEC 3 0 0 3 3
14. Pharmacogenomics PEC 3 0 0 3 3
15. Bio-entrepreneurship PEC 3 0 0 3 3
16. Biomaterials and Tissue PEC
3 0 0 3 3
Engineering
17. Advances in Omics PEC
3 0 0 3 3
Sciences and Technology
EMPLOYABILITY ENHANCEMENT COURSES (EEC)
PERIODS TOTAL
NO. CODE GORY
L T P PERIODS
PRACTICALS
1. Summer internship*** EEC 0 0 0 0 2
2. Project Work I EEC 12 12
0 0 6
3. Project Work II EEC 24
0 0 24 12
RESEARCH METHODOLOGY AND IPR (RMC)
PERIODS TOTAL
NO. CODE GORY
L T P PERIODS
Ten
THEORY
1. Research Methodology and PEC
2 0 0 2 2
IPR
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SUMMARY
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S. CREDITS PER SEMESTER TOTAL
Subject Area
NO. I II III IV CREDITS
1. RMC 2 2
2. PCC
15 13 6 37
3. PEC
6 6 12
4. OEC
3 3
5. EEC 8 12 20
TOTAL 23 24 14 12 73
ANALYTICAL TECHNIQUES IN PHARMACEUTICAL BIOTECHNOLOGY L T P C
3 0 0 3
COURSE OBJECTIVES:
 To enable the students To have a fundamental knowledge about the molecular spectroscopy,
NMR and Mass spectroscopy
 To acquire knowledge on different chromatographic methods for separation of pharmaceutical
and biotechnological products.
 To acquire knowledge about the principles and operations of various modern analytical
instruments.
UNIT I MOLECULAR SPECTROSCOPY 9

UV-Visible spectroscopy- Theory, Laws, Instrumentation, and applications; IR spectroscopy: Theory,
Molecular vibrations, Sample handling, Instrumentation of Dispersive and Fourier - Transform IR
Spectrometer and Applications; Spectroflourimetry: Theory of Fluorescence, Factors affecting
fluorescence, Quenchers, Instrumentation and Applications Atomic absorption spectroscopy: Principle,
Instrumentation, Interferences and Applications, Case studies on applications of molecular
spectroscopy.
UNIT II NMR SPECTROSCOPY 9

Quantum numbers and their role in NMR, Principle, Instrumentation, Solvent requirement in NMR,
Chemical shift, Factors influencing chemical shift, Spin-Spin coupling, Coupling constant, Nuclear
magnetic double resonance, Principles of 1H-NMR and 13C NMR. Pharmaceutical and biological
UNIT III Ten

applications of NMR spectroscopy.
MASS SPECTROSCOPY 9
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Principle, Theory, Instrumentation, Types of ionization like electron impact, chemical, field, FAB and
MALDI, APCI, ESI, APPI, Analyzers of Quadrupole and Time of Flight, Mass fragmentation and its
rules, Meta stable ions, Isotopic peaks and Pharmaceutical and biological applications of Mass
UNIT IV CHROMATOGRAPHY
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spectroscopy, Case studies on biological applications of mass spectroscopy.
affecting resolution and applications of High-performance Thin Layer chromatography, Ion exchange
chromatography, Column, Gas, High Performance Liquid chromatography and Affinity
9
Analytical & Preparative concepts of - Principle, instrumentation, chromatographic parameters, factors
chromatography, Case studies on usage of ion exchange, HPLC and affinity chromatography in
industrial applications.
UNIT V ELECTROPHORESIS & IMMUNOASSAYS 9

Principle, Instrumentation, working conditions, factors affecting separation and applications of the
following: Gel electrophoresis, Capillary electrophoresis, Zone electrophoresis, Iso electric focusing;
RIA (Radio immuno assay), ELISA and Bioluminescence assays; Analysis of host cell protein (HCP)
and host cell DNAs (HCD) in biopharmaceuticals, viable cell analysis, measurement of energy
metabolism of live cell, metabolic analyzer – principle and instrumentation.
TOTAL: 45 PERIODS
COURSE OUTCOMES:
On completion of the course, students will able to
1. Understand the fundamental principles and applications of UV-visible, IR, flame emission,
atomic absorption, NMR and Mass spectroscopy
2. Demonstrate the principles and applications of chromatographic and electrophoretic
separation techniques
3. Recognize the importance of modern instruments in the pharmaceutical analysis
4. Apply the theoretical knowledge of instruments for new analytical method development in
screening of various pharmaceutical agents.
5. Develop ability to involve in chemical and biological standardization of pharmaceutical
products.
6. Assess appropriate techniques for the analysis of various pharmaceuticals and
biotechnological products.
CO - PO mapping
Course PO1 PO2 PO3 PO4 PO5 PO6
outcomes
CO1 3 3 3 1 1 1
CO2 3 3 3 1 1 1
CO3 1 2 3 2 1
CO4 3 2 3 3 1
CO5 3 2 3 2 1
CO6 3 3 3 3
(1, 2 and 3 are correlation levels with weightings as Slight (Low), Moderate (Medium) and
Substantial (High) respectively)
REFERENCES:
1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition,
John Wiley & Sons, 2004.
2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A. Nieman,
Ten
5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers. 4. Practical
Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4thedition, CBS Publishers, New
Delhi, 1997.
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4. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.
5. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd Edition, CBS
Publishers, New Delhi, 1997.
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6. Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume 11, Marcel
Dekker Series
PHARMACEUTICAL MICROBIOLOGY L T P C
3 0 0 3
COURSE OBJECTIVES:
Upon successful completion of this course the student will be able to
 Understand the mechanism of action of chemotherapeutic and antibiotic resistence.
 Identify the microorganisms of relevance to healthcare and the pharmaceutical industry and their
sources.
 obtain the knowledge on microbial contamination/product spoilage and antimicrobial preservation
in pharmaceutical formulations
UNIT I CHEMOTHERAPEUTIC AGENTS 9

Introduction to chemotherapeutic agents: History and development of chemotherapeutic agent,
Properties of antimicrobial agents, Types of chemotherapeutic agents – Synthetic, Semisynthetic,
Natural. Antibiotics: Types of antibiotics with their mode of action; antibacterial, antifungal, antiviral,
antiprotozoal
UNIT II ANTIBIOTIC RESISTANCE AND DEVELOPMENT OF NEW THERAPEUTICS 9

Antibiotic resistance: Development of antibiotic resistance amongst pathogens Mechanism of
antibiotic resistance, Disease management methods. Antimicrobial Peptides: History, properties,
sources, mode of action, application. Plant based therapeutic agents. Different prophylactic and
therapeutic methods in control of infections. Introduction to virology.
UNIT III CLEAN ROOM TECHNOLOGY AND BIOSAFETY REGULATIONS 9

Microbial contamination spoilage and hazard Sources of contamination, factors affecting survival and
growth. Methods of sterilizations: Steam, dry heat, Radiation, Gaseous and Filtration. Clean room
technology and its regulatory aspects. Principles of sterilizations with respect to pharmaceutical
industries. Biosafety regulations- BSL-1, BSL-2, BSL-3 and BSL-4.
UNIT IV PRESERVATION OF PHARMACEUTICAL PRODUCTS 9

Principles of preservation: objectives of preservation, the ideal preservative, rational development of a
product preservative system etc. Antimicrobial preservatives and their properties: antimicrobial
activity, factors affecting antimicrobial activity, preservative monographs. Preservative stability and
efficacy. Evaluation methods of Preservative and testing.
UNIT V MICROBIAL FERMENTATIONS 9

Industrial importance of microbes in the production of Enzymes - Amylase, Invertase, Proteolytic.
Vaccines -Recombinant and Synthetic Vaccines. Organic acids-citric acid, acetic acid, and - keto
glutaric acid. Bio-insecticides-Bacillus sp., Baculovirus. Antibiotics- Penicillin, Bacitracin,
Streptomycin. Vitamins-Vitamin B12, Vitamin A, Riboflavin.
SELF STUDY TOPICS (NOT FOR EXAMINATIONS): Role of microbes in the degradation of
COURSE OUTCOMES: Ten

pollutants / toxic compounds, Microbial waste products in the market.
TOTAL: 45 PERIODS
mode of action
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CO 1 Describe the structure and types of antimicrobial chemotherapeutic agents and their
CO 2 apply the knowledge of biochemical and genetic basis for antibiotic resistance and its
control mechanism
pharmaceuticals.
e
CO 3 explain the various sterilization techniques and evaluate the sterility testing of
CO 4 Learn about various antimicrobial preservatives used in Pharmaceuticals and

its evaluation methods
CO 5 Illustrate the principle in fermentation process and techniques for antibiotics, enzymes
and vitamin production.
CO 6 Identify the microorganisms of relevance to healthcare and the pharmaceutical
industry and microbial production and evaluation of pharmaceuticals
CO-PO Mapping
outcomes
CO 1 3 2 3 1
CO 2 3 2 2 3
CO 3 3 3 2 3
CO 4 3 2 2 3 3
CO 5 3 3 2 3 3
CO 6 2 3 3 3 3 1
REFERENCES:
1. Hugo, WB and Russell, AD. Pharmaceutical Microbiology, (2003). Blackwell Science, Oxford,
UK.
2. Geoffrey Hanlon and Norman Hodges. Essential Microbiology for pharmacy and
pharmaceutical science. (2013).Wiley Blackwell.
3. S. P. Vyas & V. K. Dixit. Pharmaceutical Biotechnology. (2003) CBS Publishers &
Distributors, New Delhi.
4. Prescott's Microbiology 8th Edition by Willey, Joanne, Sherwood, Linda, Woolverton,
Chris.
5. Davis, B. D., Dulbecco, R, Eisen, H. N., Ginsberg, R. S. Microbiology. (1990). Harper and
Row Publishers, Singapore.
6. L.E. Casida, Industrial microbiology, New Age International Publishers.2005
INDUSTRIAL FERMENTATION L T P C
3 0 0 3
COURSE OBJECTIVES:
 To enable the students to understand the concepts of fermentation technology applied to
industrial processes for making products: fermenters, reaction kinetics, media formulation,
utilization of microbial cultures, design aspects of bioreactors.
UNIT I INTRODUCTION TO BIOREACTOR DESIGN AND CONSTRUCTION 9

Bioreactor selection criteria and classification, Parameters for control, Design of ideal reactors, Single
Ten
(Batch, Flow) and multiple reactors, Non-Ideal flow, RTD studies, Modelling of Non-ideal flow reactors,
Design and operation of various bioreactors, viz CSTF, fed batch systems, air-lift bioreactors, fluidized
bed bioreactors, Scale-up studies.
UNIT II
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MICROBIAL KINETICS AND DESIGN OF VARIOUS CULTIVATION
PROCESSES 9
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Immobilized and solid state cultivation; Kinetics of growth in batch continuous and fed batch culture.
Specific growth rate, doubling time, growth yield, metabolic quotient; stoichiometry- balance equation,
carbon- nitrogen balance, oxidation - reduction principles, product formation. Biomass productivity,
comparison with batch cultures, residual time distribution, test of validity; product formation, total cell
retention cultivation, . Effect of inhibitors and activators on growth.
UNIT III MODELING OF RECOMBINANT CULTIVATION ANIMAL AND PLANT CELL

CULTIVATION SYSTEMS FORTHERAPEUTIC PROTEINS 9
Structured models of metabolism and growth, models of gene expression and regulation, a
generalized model of plasmid replication, Genetic instability, predicting host-vector interactions and
genetic instability. Process considerations for utilizing genetically engineered strains. Media, aeration
in cell culture systems, Bioreactors for plant/animal suspension culture, cell immobilization and
organized tissue, bioreactor considerations for animal /plant cell culture for production of
pharmaceuticals, Therapeutic proteins and Monoclonal antibodies. Industrial applications of the
bioreactors as cell cultivation systems. Introduction to cell banking and storage -.mammalian, insects,
stem cells and Microbes.
UNIT IV DOWNSTREAM PROCESSING AND SEPARATION TECHNIQUES 9

Characteristics of biological materials: Recovery and purification of fermentation products;
pretreatment methods; Separation of cell mass: centrifugation, clarification and filtration; removal of
host cells proteins (HCP) and viral plasmids proteins, viral inactivation. Modern techniques:
Electrophoresis; Chromatographic methods; Membrane processes- Ultrafiltration; Reverse osmosis;
Cross flow filtration; Microfiltration; Isoelectric focusing; Affinity based separations. Advantages and
disadvantages of the above methods.
UNIT V CASE STUDIES IN FERMENTATION DERIVED PRODUCTS 9
Case studies on Whole cell immobilization and their industrial application. Production of penicillin,
recombinant Insulin, amino acids-lysine and glutamic acid. Enzymes -amylase and protease. Case
studies should deal with strain improvement, medium design, reactor design and process optimization
etc.
SELF STUDY TOPICS (NOT FOR EXAMINATIONS): Drying, Drying curve, Batch and continuous
dryers, Case studies for the separation of intracellular and extracellular products, Evaporation and
crystallization.
TOTAL: 45 PERIODS
COURSE OUTCOMES:
After completion of the course, a student will be able to achieve these outcomes
1. Apply the knowledge of fermentation technology in industrial processes
2. Handle and utilize microbial systems for biological reactions for making products
3. Design and use of reactor systems for bioprocesses.
4. Analyse kinetics of cell and product formation in batch, continuous and fed-batch cultures
5. Differentiate the rheological changes during fermentation process
6. Detail the downstream process of fermentation of important microbial products.
CO - PO mapping
Course
outcomes
Ten
PO1 PO2 PO3 PO4 PO5 PO6
tativ
CO1 3 2 1
CO2 2 2 1
CO3 2
e
CO4 1 1 2
CO5 1 1 1 2
CO6 1 2
REFERENCES
1. Stanbury, Stephen. P. F., Hall, J. and Whitaker, A. “Principles of fermentation technology”
Elsevier 3rd edition.
2. Bailey, J.E. and Ollis, D.F. “Biochemical Engineering Fundamentals”
2nd Edition.,McGrawHill,1986.
3. B.Sivashankar, “Bioseparation principles and techniques”. Prentice Hall of India Pvt Ltd 2007
4 Blanch, H.W and Clark D.S., “Biochemical Engineering”, Marcel Dekker,1997
5. Doran, Pauline M, “Bioprocess Engineering Principles”. Academic Press, 1995
6. Nielsen, J. and Villadsen, J. “Bioreaction Engineering Principles”. Springer, 2007.
7. Shuler, M.L. and Kargi, F. “Bioprocess Engineering: Basic Concepts”. 2nd Edition,
Prentice-Hall,2002.
RESEARCH METHODOLOGY AND IPR L T P C
2 0 0 2
COURSE OBJECTIVES:
 To impart knowledge and skills required for research and IPR:
 Problem formulation and use of various research designs
 Know different means of data collection
 How to analyze and interest as well as present data in different modes like Technical paper
writing / presentation without violating professional ethics
 Patent drafting and filing patents
UNIT I RESEARCH DESIGN 6

Overview of research process and design, Use of Secondary and exploratory data to answer the
Research question, Qualitative research, Observation studies, Experiments and Surveys.
UNIT II DATA COLLECTION AND SOURCES 6

Measurements, Measurement Scales, Questionnaires and Instruments, Sampling and methods. Data
- Preparing, Exploring, examining and displaying.
UNIT III DATA ANALYSIS AND REPORTING 6

Overview of Multivariate analysis, Hypotheses testing and Measures of Association. Presenting
Insights and findings using written reports and oral presentation.
UNIT IV
Ten
INTELLECTUAL PROPERTY RIGHTS
Intellectual Property – The concept of IPR, Evolution and development of concept of IPR, IPR
6
tativ
development process, Trade secrets, utility Models, IPR & Bio diversity, Role of WIPO and WTO in
IPR establishments, Right of Property, Common rules of IPR practices, Types and Features of IPR
Agreement, Trademark, Functions of UNESCO in IPR maintenance.
UNIT V PATENTS
e 6
Patents –objectives and benefits of patent, Concept, features of patent, Inventive step, Specification,
Types of patent application, process E-filling, Examination of patent, Grant of patent, Revocation,
Equitable Assignments, Licences, Licensing of related patents, patent agents, Registration of patent
agents, Indian Patents and Designs, Act 1911.
SELF STUDY TOPICS (NOT FOR EXAMINATIONS): Attending WIPO free courses, criteria for patentability.
TOTAL:30 PERIODS
COURSE OUTCOMES:
After completion of the course the students will be able to
CO1: Identify and formulate the research problems.
CO2: Collect the data related to research problem from different sources.
CO3: Analysis the data related to research problem.
CO4: Understand and role and responsibilities of different organization in the protection of
intellectual property rights.
CO5: Describe about patents and procedure for obtaining patents.
CO6: Understand the interrelationships between research problems and the process
procedure in filling patents in Research and Development.
CO – PO MAPPING
RESEARCH METHODOLOGYAND IPR
CO PO1 PO2 PO3 PO4 PO5 PO6
CO1 3 2 2
CO2 3 2 2
CO3 3 1 2
CO4 3 2 1 2
CO5 3 3 2 2 1 2
CO6 3 2 2 2
REFERENCES:
1. Cooper Donald R, Schindler Pamela S and Sharma JK, “Business Research Methods”, Tata
McGraw Hill Education, 11e (2012).
2. Catherine J. Holland, “Intellectual property: Patents, Trademarks, Copyrights, Trade Secrets”,
Entrepreneur Press, 2007
3. David Hunt, Long Nguyen, Matthew Rodgers, “Patent searching: tools & techniques”, Wiley,
2007.
4. S. Lakshmana Prabu, TNK. Suriyaprakash, Eduardo Jacob-Lopes, Leila Queiroz Zepka,
“Intellectual Property Rights – Patent”, InTech, Croatia, 2020.
5. The Institute of Company Secretaries of India, Statutory body under an Act of parliament,
“Professional Programme Intellectual Property Rights, Law and practice”, September 2013.
Ten
DRUG REGULATORY AFFAIRS L T P C
COURSE OBJECTIVES:
The course aims to, tativ 3 0 0 3
and at International level.
 Attain the knowledge of product safety management.
UNIT I INTRODUCTION TO DRUG REGULATORY LAWS

e
 Enable the students to learn about the drug regulatory laws and the agencies in India
 Acquire knowledge of quality drug standards and drug development approval processes
9
History, Organization and functions of USFDA, EMEA, Australia TGA, U.K. MHRA, WHO, ICH and
ISO. Indian drug regulatory authorities, Central and State regulatory bodies. Need for pharmaceutical
regulations- Drugs and Cosmetics Act and Rules 1940 with latest Amendments, Special emphasis –
Schedule M and Y. The Drugs (Price Control) Order 2013 with its amendments, The drugs and Magic
Remedies (Objectionable advertisements) Act 1954, Guidelines for evaluation of
nanopharmaceuticals in India.
UNIT II PHARMACOPOEIA 6
Purpose of Pharmacopoeias- Descriptions & Monographs; Standards and Specifications; Testing of
Drugs; Various Countries Pharmacopoeias; Indian, British, U.S, European, Japanese and
International pharmacopoeia.
UNIT III cGMPs& REGULATORY RECORDS 10

cGMP concepts – Introduction, US cGMP Part 210 and Part 211.EC Principles of GMP (Directive
91/356/EEC) Article 6 to Article 14 and WHO cGMP guidelines GAMP-5; Medical device and IVDs
Global Harmonization Task Force (GHTF) Guidance docs. Introduction, Organizational Structure,
Purpose and Functions, Regulatory Guidelines, Working Groups, Summary Technical Document
(STED), Global Medical Device Nomenclature (GMDN). Drug dossier contents - CTD (CMC section)
& data. cGMP& ICH guidelines for Accelerated stability Testing.
UNIT IV DRUG DEVELOPMENT APPROVAL PROCESS/CLINICAL TRIALS 10
Drug development stages, FDA guidelines on IND, NDA, ANDA approvals. European regulatory
agency: types of filing process (Centralized, decentralized, RMS countries), Regulation of preclinical
studies, Schedule-Y, Introduction to animal ethics; Animal rights and use of animals in the
advancement of medical technology; Introduction to laws and regulations regarding the use of
animals in research. Good Clinical Practice (ICHGCP) guidelines, History and Idea behind GLP,
Areas of Application of GLP, GMP compliance audit
UNIT V QUALITY MANAGEMENT SYSTEMS 10

Introduction to GDP, data management and integrity, Concept of Quality, Total Quality Management,
Quality by design, Six Sigma concept, Out of Specifications (OOS), Change control. Validation: Types
of Validation, Types of Qualification, Validation master plan (VMP), Analytical Method Validation.
Validation of utilities, [Compressed air, steam, water systems, Heat Ventilation and Air conditioning
(HVAC)] and Cleaning Validation. The International Conference on Harmonization (ICH) process, ICH
guidelines to establish quality, safety and efficacy of drug substances and products, ISO 13485, Sch
MIII and other relevant CDSCO regulatory guidance documents.
TOTAL:45 PERIODS
COURSE OUTCOMES:
At the end of the course the students will be able to,
1. Apply the knowledge of drug regulatory laws.
Ten
2. Acquire the knowledge of pharmacopoeia standards.
3. Know the quality guidelines and the drug regulating authorities in different countries.
4. Have an insight about drug regulatory approval process and clinical trials in pharmaceutical
industry.
tativ
5. Assure the learning of product safety management concepts in pharmaceutical industry.
6. Acquire the knowledge of drug regulatory, quality and safety management in pharmaceutical
industry
CO 1
Course outcome
CO– PO mapping
Apply the knowledge of drug regulatory laws. 1

e
Programme Outcomes (PO)
1 2
1
3 4 5
2
6
CO 2 Acquire the knowledge of pharmacopoeia 1 1

standards
CO 3 Know the quality guidelines and the drug regulating 1
authorities in different countries
CO 4 Have an insight about drug regulatory approval 2 1 1 2 3
process and clinical trials in pharmaceutical
industry.
CO 5 Assure the learning of product safety management 2 3
concepts in pharmaceutical industry.
CO 6 Acquire the knowledge of drug regulatory, quality 2 1 1 1 2
and safety management in pharmaceutical industry
REFERENCES:
1. N Udupa and Krishnamurthy Bhat. A Concise Textbook of Drug Regulatory Affairs ,
ManipalUniversity Press, Edition: 1, 2015.
2. David M.Bleisner, Establishing a cGMP Laboratory Audit System, A practical Guide, Wiley
Publication, 2006.
3. Abraham, John and Smith, H.W. “Regulation of the Pharmaceutical Industry”, Palgrave,
Macmillan, 2003.
4. Weinberg, Sandy “Good Laboratory Practice Regulations” 4th Edition,Marcel
Dekker,2007.
5. Gad, Shayne C. “Drug Safety Evaluation”, Wiley-Interscience, 3rd Edition, 2016.
6. Good Clinical, Laboratory and Manufacturing Practices Techniques for the QA
Professional, Edited by PA Carson,and N Dent,, The Royal Society of Chemistry 2007,
Published by The Royal Society of Chemistry, Thomas Graham House, Science Park,
Milton Road, Cambridge CB4 0WF, UK
7. Laboratory Auditing for Quality and Regulatory compliance bu Donald
C. Singer, Drugs and the Pharmaceutical Sciences, Vol.150. 2005.
8. Berry, Ira R. and Harpaz, Daniel “Validation of Active Pharmaceutical
Ingredients”, 2ndEdition, CRC Press, 2001
9. British Pharmacopoeia, Andesite Press, 2021.
10. United States Pharmacopoeia, 2020
11. https://cdsco.gov.in/opencms/opencms/en/Home/
12. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-
practice-cgmp-regulations
COURSE OBJECTIVES:
Ten ANALYTICAL TECHNIQUES IN PHARMACEUTICAL
BIOTECHNOLOGY LABORATORY
L T P C
0 0 6 3
tativ
 carry out analytical experiments related to spectroscopic and chromatographic techniques.
 enable students to learn the principles of analysis for pharmaceutical and biotechnological
applications
e
 provide students of various analytical skills, in relevance of pharmaceutical dosage forms
and analytical instrumentation,
LIST OF EXPERIMENTS
1. UV/Visible Spectroscopy
i) Calibration of UV spectrophotometer
ii) Effect of solvent on wavelength maxima of drugs.
iii) Validation of Beers lambert laws.
iv) Standard calibration curve by UV spectroscopy at λ max, λ max + 10 nm and λ max –
10 nm
v) Determination of pKa by U.V. spectroscopy.
vi) Multicomponent analysis by UV-Spectrophotometry by different methods
vii) Analysis of drugs from formulations focusing on separation of drug from the formulation
excipients.
2. Fluorescence spectroscopy:
i) Excitation and emission spectra for the fluorescent dye fluorescein.
ii) Effect of concentration and instrumental bandwidth on the fluorescent signal.
3. IR Spectroscopy
i) Calibration of IR spectrophotometer
ii) Sample preparation for I.R. spectroscopy (solid/liquids) and interpretation of IR bands
for important functional groups.
4. Chromatography:
i) HPLC calibration of HPLC column and determination of response factor by HPLC
ii) Separation of components by HPTLC and column chromatography.
5. Structural Interpretation by Spectroscopy:
i) Basic interpretations of simple Mass spectra and NMR.
ii) Structural elucidation workshop: Interpretation of 1H NMR, 13C NMR, IR and Mass
spectrometry of simple compounds.
TOTAL: 90 PERIODS
COURSE OUTCOMES:
At the end of the course, the student able to
1. Operate spectroscopic and chromatographic instruments.
2. Assess sources of error in instrumental analysis and perform calibration of instruments.
3. Conduct the chromatographic separation and spectroscopic analysis of drugs.
4. Interpret the structure of the organic compounds with the given spectral data.
5. Develop ability to involve in qualitative and quantitative analysis of drugs and biologics.
6. Appreciate the importance of modern instruments in the quality control and research
CO - PO mapping
outcomes
CO1 3 3 3 3
CO2 3 2 3 2 2
CO3 3 3 3 3
CO4 3 3 3 3
CO5 3 3 3 3
CO6 3
Ten 3 3 3 2
REFERENCES:
tativ
1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition,
John Wiley & Sons, 2004.
e
2. Loyd V. Allen Jr, “Remington: The Science and Practice of Pharmacy”. Vol. I & II, 22nd
Edition, Pharmaceutical Press;, 2012.
3. Kenneth A. Connors, “Textbook of Pharmaceutical Analysis”, 3rd Edition, John wiley
and sons, New York, 2007.
4. Siddiqui, Anees A, “Pharmaceutical Analysis”. Vol.I & II, 3rd edition, CBS Publishers,
2014.
5. Takeru Higuchi, Einar Brochmann, Hanffen Hanssen, Hamffen Hanssen,
“Pharmaceutical Analysis” 1st Edition, CBS Publishers, 2005.
SEMESTER II
PROTEIN AND PROTEIN FORMULATIONS L T P C
3 0 0 3
COURSE OBJECTIVES:
 To provide the basic concepts of protein and protein formulations.
 To instill the principles of protein formulation and design
 To impart knowledge and skills necessary for knowing fundamental aspects of proteins and their
formulations
UNIT I PROTEIN ENGINEERING 9

Concepts for protein engineering. Isolation and purification of proteins, Stability and activity based
approaches of protein engineering, Chemical and Physical Considerations in Protein and Peptide
Stability.
UNIT II PEPTIDOMIMETICS 9
Introduction, classification; Conformationally restricted peptides, design, pseudopeptides,
peptidomimetics and transition state analogs; Biologically active template; Amino acid replacements;
Peptidomimetics and rational drug design.
UNIT III PROTEOMICS 9

Protein identification and characterization: Methods/strategies, protein identification, de novo protein
characterization, Isotope labelling, N- and C-terminal tags. 2-Dimensional gel electrophoresis
Methods including immobilized pH gradients (IPGs), resolution, reproducibility and image analysis,
future developments. Purpose of Protein glycosylation- effect of protein glycosylation on the
proteome
UNIT IV PROTEIN FORMULATION 9

Different strategies used in the formulation of DNA and proteins, Analytical and biophysical
parameters of proteins and DNA in preformulation, Liposomes, PEGylation, Biological Activity,
Biophysical Characterization Techniques, Forced degradation studies of protein.
UNIT V METHODS OF PROTEIN SEQUENCING 9

Various methods of protein sequencing, characterisation, Edman degradation, Tryptic and/or
Chymotryptic Peptide Mapping.
TOTAL: 45 PERIODS
COURSE OUTCOMES
Ten
At the end of the course the students will be able to
1. Understand the fundamentals of protein engineering.
2. Discuss the underlying concepts of peptidomimetics and drug design.
tativ
3. Demonstrate the characterization techniques for protein molecules.
4. Incorporate approaches to formulate stable protein formulation.
5. Elicit concepts of the protein sequencing.
CO – PO mapping
Course Outcome
e
6. Become expertise in the technology of Protein and Protein Formulations
1 2 3 4 5 6
CO1 2 2 1 1
CO2 2 2 1
CO3 1 1 2 2
CO4 2 2 2 2 1
CO5 2 2 1
CO6 2 2 1 1
REFERENCES:
1. Eugene J. McNally, Jayne E. Hastedt Protein Formulation and Delivery, Informa Healthcare USA,
Inc 2008
2. Engelbert Buxbaum, Fundamentals of Protein Structure and Function, Springer International
Publishing Switzerland 2015
3. Ajay K. Banga Therapeutic Peptides and Proteins Formulation, Processing, and Delivery
Systems. 3rd Edition, 2015. CRC Press, Taylor & Francis USA.
4. Sheldon J. Park, Jennifer R. Cochran, Protein Engineering and Design, 1ST Edition, 2009, CRC
press. USA
5. Jeffrey L. Cleland, Rober Langer. Formulation and Delivery of Proteins and Peptides. ACS, USA.
6. Robert K. Skopes. Protein purification, principles and practice, springer, New york.
7. David Whitford, Proteins-Structure and Function, 1st Edition, 2005. John Wiley & Sons, USA.
8. Lars Hovgaard, Sven Frokjaer, Marco van de Weert. Pharmaceutical Formulation Development of
Peptides and Proteins. 2nd Edition, CRC Press, Taylor & Francis, USA.
IMMUNOTECHNOLOGY L T P C
3 0 0 3
COURSE OBJECTIVES:
The course aims to
 understand the applications of immunology for the development of diagnostics
 understand the basic principles of vaccine development
 make use of the knowledge of immunotechnology for clinical applications and also become
aware of the regulatory issues.
UNIT I INTRODUCTION 6
Ten
Review on Cells of the immune system and their development; primary and secondary lymphoid
organs; humoral immune response; cell mediated immune responses; complement, classification of T
cells and B cells, cell markers.
UNIT II ANTIBODIES
tativ 11
Development of Monoclonal antibodies, classification and their applications; ELISA – types; IFT
e
(direct and indirect) Agglutination tests; Antigen detection assay; Plaque Forming Cell Assay,
Development of rapid immunodiagnostics - Immuno- lateral flow / flow through assays. Diagnosis of
immediate and delayed hypersensitivity, anaphylactic reaction, total Ig and antigen specific IgE
antibody assay, assay for hemolytic diseases, assay for immune complex, skin tests for DTH
response
UNIT III DEVELOPMENT OF IMMUNOASSAYS 10

PBMC separation from the blood; identification of lymphocytes based on CD markers; FACS;
Lympho proliferation assay; Mixed lymphocyte reaction; Cr51 release assay; macrophage cultures;
cytokine bioassays- IL2, gamma IFN, TNF alpha.; HLA typing.
UNIT IV VACCINE TECHNOLOGY 10

Principles of vaccine development, types; Development of vaccines for bacterial, viral and parasitic
diseases, Regulatory requirements for vaccine development and testing, ethical issues, protein based
vaccines; sub-unit vaccines, DNA vaccines; Plant based vaccines; recombinant antigens as vaccines;
reverse vaccinology, cancer vaccines, customized therapeutic cancer vaccines, (scFv) antibodies and
molecular evolution of scFv for enhanced sensitivity and specificity,
UNIT V DEVELOPMENT OF IMMUNOTHERAPEUTICS 8

Development of effective immuno drug targets for infectious diseases, engineered antibodies; catalytic
antibodies; idiotypic antibodies; dendritic cells based immunotherapy, combinatorial
libraries for antibody isolation, CAR T-cell therapy, Immune check point inhibitors.
TOTAL: 45 PERIODS
COURSE OUTCOMES:
1. understand the science of immunotechnology
2. comprehend the concepts of antibodies and its characterization
3. describe the developments in the immunoassays
4. gain the knowledge of vaccine development
5. apply the technology for the development of immunotherapeutics and Diagnosis
6. become an entrepreneur in the field of immunotechnology
CO – PO mapping
Course Programme Outcomes (PO)
Outcomes
1 2 3 4 5 6
CO1 3 2 1
CO2 2 2 1
CO3 2 2
CO4 1 1 2 2
CO5 1 1 1 2 2
CO6 2 2 2
REFERENCES:
Ten
1. Roitt, Ivan. Essential Immunology 9th Edition., Blackwell Scientific, 13th edition, 2017
tativ
2. Roitt I., Brostoff J. and Male D. Immunology, 6th ed. Mosby, 2001
3. Goldsby , R.A., Kindt, T.J., Osbome, B.A. and Kerby J. Immunology, 6th ed., W.H.Freeman,
2006
4. Janeway's Immunobiology, Ninth Edition, Kenneth M. Murphy, Casey Weaver, 2017
R.Burton, Ivan M. Roitt, 2017

6. Lippincott Illustrated Reviews: Immunology, 2nd ed., 2012 e
5. Roitt's Essential Immunology, 13th Edition, Peter J. Delves, Seamus J. Martin, Dennis
TECHNIQUES IN MOLECULAR BIOLOGY AND GENETIC L T P C

ENGINEERING 3 1 0 4
COURSE OBJECTIVES:
 This course is aimed to teach students with different approaches to perform molecular biology,
genetic engineering, rDNA technology and their practical applications in biotechnological
research as well as in pharmaceutical industries.
UNIT I VECTOR SYSTEMS 12

Overview of tools in recombinant DNA technology. Artificial chromosomes – YACs and BACs.
Principles for maximizing gene expression – expression vectors, pMal, GST, pET-based
vectors. Protein purification – His-tag, GST-tag and MBP-tag. Intein-based vectors; Inclusion
bodies; methodologies to reduce formation of inclusion bodies; mammalian expression and
replicating vectors; Baculovirus and Pichia vectors system, plant based vectors, Ti and Ri plasmids
as vectors,yeast vectors and shuttle vectors.
UNIT II ASSAY TECHNIQUES IN MOLECULAR BIOLOGY 12

Nuclease protection assays, Nuclease S1 mapping, Reporter assays – Mono and dual reporter
assays, Electrophoretic mobility shift assay (EMSA) / Gel shift assay, Run-off transcription assay,
Phage display, Ribosome display, Gene silencing – siRNAs and Morpholinos.
UNIT III HIGH-THROUGHPUT DNA SEQUENCING 12

Preparation of Next Generation Sequencing (NGS) libraries: Fragmentation versus tagmentation, end
repair, clonal amplification – Bridge PCR and emulsion PCR. Basics and steps involved in NGS
platforms: Illumina/Solexa, Roche 454, Ion-torrent and Pacific biosciences. Current status of Oxford
nanopore sequencing. Principles of Mate pair sequencing, ChIP-seq, RIP/CLIP-Seq, Methyl seq
– Restriction enzyme, enrichment and bisulfite treatment strategies.
UNIT IV GENE EXPRESSION ANALYSIS 12

Overview of gene expression and its significance. Hybridization methods: Southern and Northern.
PCR methods: Reverse transcriptase PCR, End point Vs Real time PCR, Relative quantitation,
Absolute quantification – Standard curve method and digital PCR. Endogenous/loading controls.
High throughput analysis: Multiplex PCR, Microarray, Serial analysis of gene expression (SAGE)
and Small Amplified RNA-SAGE (SAR-SAGE), Total analysis of gene expression (TOGA), Gene
calling, RNA-seq and Ribosome profiling.
UNIT V GENOME EDITING TECHNOLOGIES 12

Basics and applications of genome editing methods - Zinc-finger nuclease (ZFN), Transcription
activator-like effector nucleases (TALEN), Mega nucleases, CRISPR-Cas systems – Types and
applications, Homing endonucleases, Transposons and Cre/lox P systems. Gene delivery systems –
Physicochemical methods and viral vectors.
COURSE OUTCOMES:
Ten
By the end of the course, the student should be able to
TOTAL: 60 PERIODS
tativ
1. detail the basic steps of gene cloning and the role of enzymes and vectors responsible for
gene manipulation, transformation and genetic engineering.
2. apply concept of genetic engineering techniques in basic and applied experimental biology.
further studies in the area of genetic engineering.

e
3. possess proficiency in designing and conducting experiments involving genetic manipulation.
4. demonstrate the skills on gene manipulation, gene expression, etc which prepares them for
5. illustrate technical know-how on versatile techniques in recombinant DNA technology.

6. describe the genome editing and sequencing and methods for gene therapy..
. CO – PO mapping
Course Outcome Programme Outcomes (PO)

1 2 3 4 5 6
CO1 3 2 1
CO2 2 2 1
CO3 2 2
CO4 1 1 2 2
CO5 1 1 1 2 2
CO6 2 2
REFERENCES:
1. Steven R. Head, Phillip Ordoukhanian, Daniel R. Salomon. “Next Generation
Sequencing:Methods and protocols” 1st Edition, Humana Press, 2018.
2. Krishnarao Appasani. “Genome Editing and Engineering” Cambridge University press 2018.
3. Raghavachari Nalini, Garcia-Reyero Natàlia. “Gene expression analysis:
Methods and protocols” 1st Edition, Humana Press, 2018.
4. Primrose SB and Twyman RB. “Principles of Gene manipulation and Genomics”.
7th Edition,Wiley-Blackwell, 2006.
5. Green MR and Sambrook J. “Molecular Cloning: A Laboratory Manual”. 4th Edition,
CSHL press, 2012.
IMMUNOTECHNOLOGY LABORATORY LT PC
0 0 6 3
COURSE OBJECTIVES
The course aims to,
 provide hands-on-experience on handling animal for research and various relevantI
immunological techniques like ELISA, Flow cytometry etc.
 provide practical experience on performing and understanding immunoassays forevaluating
drugs.
 to obtain laboratory training for different Immunotechnological techniques.
LIST OF EXPERIMENTS
1.*Preparation of antigen and Routes of immunization (Intraperitoneal, Sub-cutaneous,
Intramuscular, Intra- nasal, Oral – VIRTUAL DEMO)
Ten
2. *Methods of bleeding (Tail bleeding, Intravenous, intraorbital - VIRTUAL DEMO)
3. Collection of serum, storage and purification of total IgG (salt precipitation).
tativ
4. Evaluation of Antibody titre by direct ELISA
5. Evaluation of Antigen by Sandwich ELISA
6. Characterization of antigens by native and SDS-PAGE
e
7. Characterizations of antigens by Western blot analysis – Wet and semi dry transfer
8. Conjugation of Immunoglobins (Streptavidin, colloidal gold)
9. Methods for prototype development of Immunodiagnostics (ICT card)
10. Blood smear identification of leucocytes by Giemsa stain 16
11. Separation of mononuclear cells by Ficoll-Hypaque
12. Separation of splenocytes and proliferation against mitogens
13. Primer design using softwares.
14. Gene DNA amplification by random / specific primers.
15. Western Blotting
16. Gene amplification by PCR.
TOTAL: 90 PERIODS
LIST OF EQUIPMENTS REQUIRED
Microscopes
Purification columns
Microplate reader
UV spectrometer
PAGE apparatus
Western blot apparatus
Centrifuge
Haemocytometer
Cell counter
Metabolic analyser
PCR
COURSE OUTCOMES
At the end of the course, learners will be able to
CO 1De Demonstrate the immunization methods and handling of animals

CO 2 Carry out the experiment on immunological assays for identifying drugs and
vaccines.
CO 3 Describe the principles of PCR and their uses in genetic engineering.
CO 4 Illustrate the principle, detection and quantification of protein by bioanalytical
techniques
CO 5 Learn about the gene amplification and methods for analysis of DNA
CO 6 Apply methods adapted in gene synthesis
CO-PO Mapping
outcomes
CO 1 2 2 3 3
CO 2 3 2 3 3
Ten
CO 3 3 3 3
CO 4 3 3 2 3 3
CO 5 3 2 3 3 2
REFERENCES:
CO 6 2
tativ 3 2
1. “Antibodies”, Cold Spring Harbour Laboratory, 1988.
e
2. Goldsby, R.A. et al.“Kuby Immunology”. 6thEdition, W.H. Freeman, 2002.
3. Turgeon, Mary Louise. “Immunology and Serology in Laboratory Medicine”, 2ndEdition,
Elsevier, 2007.
4. Brostoff J et al., “Clinical Immunology”, 6th Edition, Gower Medical Publishing, 2002.
5. Coligan, J. E. et al, “Current Protocols in Immunology”, 4thEdition John Wiley & Sons, 1994.
6. Paul, “Fundamental of Immunology”, 4thEdition, Lippincott Raven, 1999.
DRUG DISCOVERY LABORATORY LT PC
0 0 6 3
COURSE OBJECTIVES:
This course will explore the process of drug discovery from Synthetic and natural products .
SYNTHETIC METHODS FOR DRUG DISCOVERY

1. Synthesis of selected drugs involving two or more steps of synthesis and study of spectral
analysis
of drug synthesized (Paracetamol, Aspirin, Fluorscein, acetanilide, etc.).
2. Determination of pharmacopoeia standards for the synthesized drugs.
DISCOVERY OF DRUGS FROM NATURAL PRODUCTS

1. Extraction Techniques: Cold maceration, Hot Percolation and Soxhalation.
2. Evaluation of extraction Efficiency by yield calculation and TLC.
3. Isolation and purification of some of the following natural products
a. Piperine from black pepper
b. Strychnine and Brucine from Strychnos nuxvomica seeds
c. Caffeine from Tea Powder
d. Curcumin from Turmeric
e. Diosgenin from Diascoria tubers
f. Sennosides from Senna leaves
Ten
g. Embelin from Emblica ribes fruits
4. Identification of alkaloids in mixture by TLC.
TLC.
tativ
5. Identification of phytoconstituents like alkaloids, steroids, flavanoids etc in plant extracts by
6. Separation (of sugars/amino acids) by paper chromatography.

7. Separation of compounds by HPLC
8. Analysis of recorded spectra of some simple organic compounds.
e
9. Tests to detect alkaloids, steroids, flavanoids and their glycosides.
10. Evaluation of antioxidant potential of herbal extracts using DPPH free Radical scavenging
assay.
TOTAL: 90 PERIODS
Required Equipments:
Soxhlet apparatus, rotary flash evaporator, Hot air oven, sonicator, mortar and pestle, TLC
chamber, Fume hood, purification columns, micro-plate reader, UV spectrometer, centrifuge,
required strains & consumables.
COURSE OUTCOMES:
On completion of this course students should be able to
1. describe the process of drug discovery and development.
2. discuss the challenges faced in each step of the drug discovery process .
3. have gained a basic knowledge of synthetic and extraction methods used in drug discovery.
4. organise information into a clear report.
5. demonstrate their ability to work in teams and communicate scientific information effectively.
6. perform common extraction techniques including maceration, percolation, soxalation etc.
CO-PO Mapping
outcomes
CO 1 2 2 2
CO 2 3 1 2 2 2
CO 3 3 1 2 2
CO 4 3 3 2 3 3
CO 5 3 2 3 2
CO 6 2 3
REFERENCES
1. Foye's Principles of Medicinal Chemistry. By David A. Williams, Thomas L.Lemke, Thomas L.
Lernke, William O. Foye. Lippincott Williams& Wilkins Publishers; 7th Edition,2012.
2. Modern Methods of Plant Analysis – Peech and M. V. Tracey, 1955.
3. Natural Product Chemistry “A laboratory guide” by Raphealikan,2nd edition, 1991.
4. Phytochemistryvol I & II by Miller, Jan, Nostrant, Rein Hid, 2003.
5. Recent advances in Phytochemistry Vol. I & IV – Scilicet, Runeckles.
6. Remington: The Science and Practice of Pharmacy, 21st Edition, 2011.
7. Wilson and Gisvold's Textbook of Organic Medicinal and Pharmaceutical Chemistry. ByJaime
N. Delgado (Editor), Ole Gisvold (Editor), William A. Remers (Editor). Lippincott Williams&
Wilkins Publishers; 10thEdition (August 1998) ISBN: 0397515839.1998
Ten
tativ
SEMESTER III
e
PROTEIN AND PROTEIN FORMULATIONS LABORATORY LT PC
0 0 6 3
COURSE OBJECTIVES
The course aims to
 Impart the knowledge of the formulation concepts on proteins.
 Evaluate the various protein and protein formulations through various characterization
techniques.
 Expertise in various formulation approaches of proteins.
LIST OF EXPERIMENTS
 Preformulation study with suitable proteins and peptides
 Study on factors influencing solubility profile and partition coefficient of proteins.
 Compatibility and interactions studies of peptides and proteins with pharmaceutical
excipients
 Stability study of protein and protein formulations
 Protein estimation using various methods.
 Isolation and estimation of DNA
 Isolation and estimation of RNA
 Estimation of Enzymatic activity.
 Prepare and characterize protein immobilized alginate beads.
 Quality control experiments with marketed protein and protein formulations
 Formulation and characterisation of vesicle based protein and peptide.
 Computational approaches in study of aggregation
LIST OF EQUIPMENTS REQUIRED
 UV Spectrophotometer
 pH Meter
 Analytical Weighing Balance
 Microscopes
 Stability Chamber
 Software for computational works to characterize the protein and protein formulations
TOTAL: 90 PERIODS
COURSE OUTCOMES:
On completion of the course, the student will be able to
1. Execute preformulation study on protein formulations.
2. Carryout the stability protocol on proteins.
3. Isolate and estimate DNA and RNA.
4. Formulate the various protein formulations.
5. Analyse the various quality control test on marketed formulations.
6. Become Expertise in the field of protein formulation discipline
CO – PO mapping
Course Outcome Programme Outcomes (PO)
1 2 3 4 5 6
Ten
CO1
CO2
3
2
1
2
1
1
1
1
1
1
CO3
CO4
2
3 tativ
1
2
1
2 2 2
CO5
CO6
2
2
2
2
1 2
2 e 2
2
BIOINFORMATICS AND COMPUTATIONAL BIOLOGY LABORATORY LT PC
0 0 6 3
COURSE OBJECTIVES:
The course aims to,
 introduce biopharma related databases, 3D structures of drugs, small molecules and targets
 get familiarized with Next Generation Sequencing Data analysis in a disease context
 perform Quantitative Structure Activity Relationship, Molecular Docking and simulations
LIST OF EXPERIMENTS
1. Introduction to Multiuser Operating System Linux.
2. Databases : Biological and Pharma related.
3. Computing molecular properties of drugs / compounds.
4. Molecular modeling of small molecules : obtaining 3D structures, understanding data
formats.
5. Drug targets, Data resources and PDB structures.
6. Homology modeling of Protein Targets and Model evaluation.
7. Next Generation Sequencing Data Analysis Bioconductor Package for Differential gene
expression analysis using a disease related dataset.
8. Quantitative Structure Activity relationship (QSAR) Model (partition co-efficient,
dissociation constant, molar refractivity, etc.)
9. Pharmacophore identification.
10. Drug like property evaluation of compounds and ADME (Lipinski's rule of five).
Ten
11. Methodology of building and refining protein drug targets structure models from X-ray
crystallographic data using CCP4i.
12. Molecular docking : Protein – Protein, Protein-Small Molecule.
tativ
13. Molecular Dynamics Simulation using GROMACS.
14. Pharmacogenomics : Effect of SNPs / mutations on drug binding using docking
approaches.
COURSE OUTCOMES:
At the end of the course the student will be able to,
1. Classify different types of Biological Databases. e TOTAL : 90 PERIODS
2. retrieve data related to small molecules, drugs and their targets, use computational tools
for their analysis.
3. explain about biological macromolecular structures and structure prediction methods
4. perform basic next generation sequencing data analysis.
5. perform computational structural studies like QSAR, Molecular docking, Molecular
Dynamics simulations and interpret the results.
6. Present and discuss experimental results
REFERENCES:
1. Introduction to Bioinformatics by Arthur K. Lesk, Oxford University Press.2014
2. Algorithms on Strings, Trees and Sequences by Dan Gusfield, Cambridge University
Press.2004
3. Biological Sequence Analysis Probabilistic Models of proteins and nucleic acids by
R.Durbin, S.Eddy, A.Krogh, G.Mitchison, Cambridge University Press,1998
4. Bioinformatics Sequence and Genome Analysis by David W. Mount, Cold Spring Harbor
Laboratory Press. 2004
5. Bioinformatics The Machine Learning Approach by Pierre Baldi and SorenBrunak,
Cambridge University Press,2001
6. RNA-seq Data Analysis: A Practical Approach, by Eija Korpelainen, Jarno Tuimala,
Panu Somervuo, Mikael Huss and GarryWong. CRC Press 2014
7. Next Generation Sequencing Data Analysis, by XinkunWang CRC Press.2016
PROJECT WORK I LT P C
0 0 12 6
COURSE OBJECTIVES:
The course aims to enable the students to
 identify the problem/process relevant to their field of interest that can be carried out
 search databases and journals to collect and analyze relevant data
 plan, learn and perform experiments to find the solution
 prepare project report
TOTAL : 180 PERIODS
COURSE OUTCOMES:
1. Identify the research/industrial problems
2. Collect the relevant literature
3. Analyze the relevant literature
4. Design the experiment
5. Conduct experiment and analyse the data
6. Prepare project report
CO - PO mapping

outcomes
Ten
CO1 2 1 2 1 2 1
CO2 2 1 2 1 1
CO3 2 1 2 1
CO4
CO5
CO6
2
2
1
1
1 tativ
2
2
2
1
1 2
1
1
1
SUMMER INTERNSHIP
e LT P C
0 0 0 2
COURSE OBJECTIVES:
1. To strengthen the association of students with Pharma/Biotech Industry.
2. To create awareness amongst the students the recent trends in Pharma/Biotech
industries.
3. To percept the role and responsibility of pharmaceutical biotechnologists in
Pharma/Biotech industries.
COURSE OUTCOMES:
After completion of the internship students will be able to:
1. learn the application of knowledge in real world problems.
2. expose to team-work and leadership quality.
3. deal with industry-professionals
4. familiarize with ethical issues in the work environment.
5. get self-motivation in learning the courses
6. identify the gap between the professional world and the academic institutions.
CO Vs PO mapping
outcomes
CO1 1 1 1 2
CO2 2
CO3 3
CO4 1
CO5 1 3 2
CO6 1 2
SEMESTER IV
PROJECT WORK II LT P C
0 0 24 12
COURSE OBJECTIVES:
Ten
The course aims to
 Train students to analyze the problem/ think innovatively to
develop new methods/product /process
tativ
 Make them understand how to find solutions/ create products economically and in an
environmentally sustainable way
 Enable them to acquire technical and experimental skills to conduct experiment, analyze the
e
results and prepare project report
 Enable them to effectively think about strategies to commercialize the product.
TOTAL : 360 PERIODS
.COURSE OUTCOMES:
At the end of the project the student will be able to
1. Formulate and analyze problems for developing new methods/solutions/processes.
2. Plan experiments to find solutions in a logical manner
3. Conduct experiments to find solutions in a logical manner
4. Analyze and interpret the results
5. Prepare project report
6. Know the strategies for Commercialization
CO - PO mapping
outcomes
CO1 3 2 3 2 3 2
CO2 3 2 3 2
CO3 3 2 3 2 3 2
CO4 3 2 3 2
CO5 2 2
CO6 2
SEMESTER I
ELECTIVE I
APPLIED STATISTICS FOR BIOTECHNOLOGISTS L T P C

3 0 0 3
COURSE OBJECTIVES:
This course will help the students to
 Study the mathematical aspects of probability, determination of probability and moments.
 Study the distributions of discrete and continuous random variables and their properties.
 Obtain the covariance and correlation between jointly distributed random variables, interpret
simple linear regression and fitting of curves by least square method.
 Study concepts and methods of sampling and various statistical tests in testing
hypothesis on data.
 Analyze one-way, two-way and three-way classifications of analysis of variance and
problems using them.
UNIT I PROBABILITY AND RANDOM VARIABLES 9

Sample spaces - Events - Axiomatic approach to probability - Conditional probability - Additional
Ten
theorem - Multiplication theorem - Baye’s theorem – Random variables : Continuous and discrete
random variables - Distribution function - Expectation with properties - Moments, mean, variance
problems - Continuous and discrete distributions.
UNIT II STANDARD DISTRIBUTIONS
tativ 9
Bivariate distribution - Conditional and marginal distribution - Discrete distributions - Binomial,
Poisson, Geometric distributions - Continuous distributions - Normal, Exponential and Negative
exponential, Gamma distributions - Simple problems - Properties.
UNIT III CORRELATION AND REGRESSION e 9

Correlation coefficient - Properties - Problems - Rank correlation - Regression equations - Problems -
Curve fitting by the method of least squares - Fitting curves of the form ax+b , ax2+bx+c , abx and axb
- Bivariate correlation application to biological problems.
UNIT IV SAMPLING AND TESTING OF HYPOTHESIS 9

Concept of sampling - Methods of sampling - Sampling distributions and standard error - Small
samples and large samples - Test of hypothesis - Type I & Type II Errors - Critical region - Large
sample tests for proportion, mean - Exact test based on normal , t , F and Chi - square distribution
problems - Test of goodness of fit.
UNIT V ANALYSIS OF VARIANCE 9

Basic principles of experimentation - Analysis of variance - One - way, Two - way classifications -
Randomized block design - Latin square design - Problems.
TOTAL: 45 PERIODS
COURSE OUTCOMES:
CO1 illustrate Mathematical basis and foundations of probability and statistics, computation of
probabilityand moments, standard distributions of discrete and continuous random
variables and
standard distributions and their properties
CO2 compute the covariance and correlation between jointly distributed variables.
CO3 categorize and interpret simple linear regression and least square methods between
two variables.
CO4 describe methods of sampling and application of various statistical tests in testing
hypotheses on data
CO5 build one-way and two-way classifications of analysis of variance, properties and
assumptions,randomized block design and Latin square design problems
CO6 Perform model selection in a multiple linear regression modelling context.
CO Vs PO mapping
outcomes
CO1 3 3 3 2
CO2 2 2 3
CO3 3 2 3 2
CO4 3 2 3 2
CO5 2
CO6 2
REFERENCES:
1. Devore, J. L., "Probability and Statistics for Engineering & Sciences", 8th Edition,
CengageLearning, 2014.
Ten
2. Gupta. S.C and Kapoor, V.K,. "Fundamentals of Mathematical Statistics", 12th Edition,
tativ
SultanChand and Sons, New Delhi, 2020.
3. Johnson, R.A., Miller, I and Freund J., "Miller and Freund’s Probability and Statistics for
Engineers", 9th Edition, Pearson Education, Asia, 2016.
4. Rice, J. A., "Mathematical Statistics and Data Analysis", 3rd Edition, Cengage Learning, 2013.
Elsevier, 2020.
THERMODYNAMICS FOR BIOLOGICAL SYSTEMS

e
5. Ross, S. M., "Introduction to Probability and Statistics for Engineers and Scientists", 6th Edition,
L T P C
3 0 0 3
COURSE OBJECTIVES:
 Students will learn about the behavior of fluids, laws of thermodynamics, thermodynamic
property relations and their application in different chemical processes
UNIT I THERMODYNAMIC LAWS 9

Basic thermodynamic concepts, Energy and first Law; Reversibility and second Law; Review of Basic
Postulates, equation of state and its applications, corresponding states, equilibrium criteria, Legendre
Transformation and Maxwell’s relations
UNIT II GIBBS PHASE RULE 9

Phase rule, Stability of thermodynamic systems, first order phase transitions and critical phenomenon,
single component phase diagrams, thermodynamic properties from volumetric and thermal data
UNIT III SOLUTION THERMODYNAMICS 9

Partial molar properties, Gibbs-Duhem equation, fugacities in gas and liquid mixtures, activity
coefficients, Ideal and Non-ideal solutions, azeotropes, Wilson, NRTL, and UNIQUAC equations,
UNIFAC method.
UNIT IV PHASE EQUILIBRIA 9
Vapour Liquid Equilibrium involving low pressure, high pressures and multi component
systems,VLE in ideal and non- ideal solutions, Henry’s Law, Other phase equilibriums-
SLE/LLE/VLLE.
UNIT V CHEMICAL EQUILIBRIA 9

Criteria of chemical reaction equilibrium in thermodynamic systems, Homogeneous gas and liquid
phase reactions, heterogeneous reactions – phase and chemical equilibrium
TOTAL: 45 PERIODS
COURSE OUTCOMES:
Upon successful completion of this course, the student will be able to:
1. Understand the basic concepts, laws and different process related to chemical engineering
thermodynamics.
2. characterize the chemical state of a system, and predict the equilibrium relations of the phases
present as a function of physical conditions such as pressure and temperature
3. Understand the thermodynamic potential, its correlation and analyze and distinguish between
ideal and non-ideal solution.
4. Understand and demonstrate the activity coefficient and activity property of solution.
5. Demonstrate the Chemical and phase equilibria equations
6. Understand the interrelationships between different thermodynamic properties and become
processes.
Ten
familiar with the graphs to develop an intuition for the variation of these properties during various
CO - PO mapping
Course
outcomes
CO1
PO1 PO2
tativ
PO3 PO4 PO5 PO6
CO2
CO3
CO4
CO5
2
3
2
3
1
2
2
2
2
2
2
1
2
2
2
e
CO6 2 2 2 2
REFERENCES:
1. M. Smith, H. C. Van Ness and M. M. Abbott; Introduction to Chemical Engineering
Thermodynamics, Tata-McGraw Hill (2003).
2. Sandler; Chemical, Biochemical, and Engineering Thermodynamics, John Wiley &Sons, New
Delhi (2007).
3. Koretsky, M. D.; Engineering and Chemical Thermodynamics, John Wiley and Sons, NewDelhi
(2004).
4. Callen, H. B. Thermodynamics and an Introduction to Thermostatistics; John iley and Sons: New
York (1985).
5. Tester, J. W., Modell, M., Thermodynamics and its Applications, Prentice-Hall, New
Jersey(1996).
6. Rao., Y.V.C., Chemical Engineering Thermodynamics, University Press, Hyderabad,2005
7. Narayanan K.V”A Text Book of Chemical Engineering Thermodynamics ”Prentice Hall of India
Pvt.Ltd.2001..
ENZYME ENGINEERING AND TECHNOLOGY L T P C
3 0 0 3
COURSE OBJECTIVES:
 To understand the IUBMB system of enzyme classification
 To know the catalytic activity of enzyme and its regulation
 To learn the enzyme immobilization; methods of immobilizing the enzymes and their
kinetics
 To learn the significant features of the biochemical catalyst
UNIT I INTRODUCTION 9
Introduction to enzymes, Classification, Sources, Mechanism of enzyme action. Strategies of
purification of enzymes, criteria of purity, molecular weight determination and characterization of
enzymes, Enzymes of biological importance - Acetyl cholinesterase, angiotensin converting
enzyme (ACE), ACE Inhibitors, HMG Co A reductase inhibitors, pseudo cholinesterase, 5’-
nucleotidase (5NT), glucose-6-phosphate dehydrogenase (GPD), Isoforms,
immunoreactivetrypsinogen (IRT) and chymotrypsin; amylase isoenzymes
UNIT II KINETICS OF ENZYME ACTION 9

Methods for investigating the kinetics of enzyme catalyzed reactions – Initial velocity Studies,
Estimation of Michaelis Menten parameters, Effect of pH and temperature on enzyme activity,
UNIT III Ten

kinetics of inhibition. Modeling of rate equations for single and multiple substrate reactions
IMMOBILIZED ENZYMES 9
tativ
Techniques of enzyme immobilization; kinetics of immobilized enzymes, effect of solute, partition
& diffusion on the kinetics of immobilized enzymes, design and configuration of immobilized
enzyme reactors; applications of immobilized enzyme technology, Economic argument for
immobilization
UNIT IV ENZYMES IN FUNCTIONAL GROUP TRANSFORMATION

e
Functional group interconversion using enzymes (hydrolysis reaction, oxidation/reduction
reactions, C-C bond formations), Retrosynthetic biocatalysis, Chemoenzymatic synthesis of
natural products. Industrial process using enzymes for production of drugs, fine chemicals and
9
chiral intermediates, Catalytic antibodies, The design and construction of novel enzymes, artificial
enzymes, Biotransformation of drugs (hydroxylation of Steroids).
UNIT V APPLICATIONS OF ENZYMES 9

Enzymes in organic synthesis, Enzymes as biosensors, Enzyme for environmental application,
Enzymes for molecular biology research, Enzymes for analytical and diagnostic applications.
TOTAL: 45 PERIODS
COURSE OUTCOMES:
Upon successful completion of this course, students will be able to:
1. describe about the enzyme and its classification, reaction in order to proceed towards
various concepts in biotechnology.
2. illustrate the enzyme kinetics which will provide the importance and utility of enzyme
towards research.
3. discuss about the enzyme immobilization techniques and its application in food,
pharmaceutical and chemical industries.
4. elaborate and explain how enzymes are used in a broad spectrum of industrial processes
and describe how different enzymes can be modified for optimal performance in these
processes.
5. Defend the enzyme applications in the field of organic synthesis, electronics, environment,
research and diagnostics.
6. acquire knowledge on biological, chemical, physical and mathematical principles which
constitute the basis of bioengineering applications.
CO Vs PO mapping
outcomes
CO1 2 3 2 2
CO2 3 2 2 1
CO3 2 2 2 2
CO4 2 1
CO5 3 2 1
CO6 2 2 2
REFERENCES:
1. Bailey J.E., Ollis D.F. “Biochemical Engineering Fundamentals.”. McGraw Hill, 2nd
Edition1986.
2. Faber, Kurt “Biotransformations in Organic Chemistry: A Textbook.”, 5th Edition.
Springer, 2008.
3. Palmer, Trevor. “Enzymes: Biochemistry, Biotechnology, Clinical Chemistry.” 2nd
Edition, East West Press, 2008.
4. Blanch H.W., Clark D. S., “Biochemical Engineering”, Marcel Dekker, Inc. 2nd Edition, 1997.
5. Lee, James M., “Biochemical Engineering.” PHI, 1st Edition, 1992.
Ten
Yeh W.K., Yang H.C., James R.M., “Enzyme Technologies: Metagenomics, Biocatalysis and
Biosynsthesis”, Wiley- Blackwell, 1st Edition, 2010.
tativ
METABOLIC PROCESS AND ENGINEERING
COURSE OBJECTIVES: e L T P C
3 0 0 3
 This course aims to provide fundamental and advanced knowledge in the development of
microbial strain for bio production through metabolic engineering.
UNIT I CELLULAR METABOLISM 9

Transport Processes – Fueling reactions – Glycolysis, fermentative pathways – TCA cycle
andoxidative phosphorylation, anaplerotic pathways –Catabolism of fats, organic acids, and
aminoacids - Biosynthesis of aminoacids, nucleic acids, and fatty acids – Polymerization –
Growth energetics.
UNIT II REGULATION, MANIPULATION AND SYNTHESIS OF METABOLIC

PATHWAY 9
Regulation of enzyme activity – Regulation of enzyme concentration – Regulation of
metabolic networks – Regulation at the whole cell level – Metabolic pathway
manipulations – Enhancement of Product yield and productivity – Extension of substrate
range, product spectrum and novel products (Antibiotics, Polyketides, Vitamins) –
Improvement of cellular properties – Metabolic pathway synthesis algorithm – Lysine
biosynthesis.
UNIT III ANALYSIS AND METHODS FOR THE METABOLIC FLUX 9

Metabolic flux map – Fluxes through the catabolic pathways in microbes– Metabolic flux
analysis for determined, over-determined and under-determined systems –Sensitivity
analysis – Direct flux determination from fractional label enrichment – Applications involving
complete enumeration of metabolite isotopomers – Carbon metabolite balances-GC-MS for
metabolic flux analysis – genome wide technologies
UNIT IV GENOME BASED METABOLIC MODEL DEVELOPMENT 9

Development of Genomic scale metabolic model, Insilico Cells:studying genotype-phenotype
relationships using constraint-based models, case studies in E. coli, S.cerevisiae metabolic
network reconstruction methods, optimization of metabolic network, Identification of targets for
metabolic engineering; software and databases for genome scale modeling
UNIT V ANALYSIS OF METABOLIC CONTROL AND INDUSTRIAL CASE

STUDIES 9
Fundamental of Metabolic Control Analysis (MCA), MFA, and MPA and their application, Multi-
substrate enzyme kinetics, Metabolic engineering examples for bio-fuel, bio-plastic and green
chemical synthesis , Study of genome scale model in various systems for the production of
green chemicals using software tools
TOTAL: 45 PERIODS
COURSE OUTCOMES:
1. highlights the engineering of the biology of microbes for maximal metabolite production.
2. summarize the cellular transport process, Regulation of enzyme activity and metabolic
pathway synthesis algorithm.
Ten
3. acquire foundational technical knowledge of the production of biosynthetic products
through recombinant DNA technology.
4. implement genome-scale metabolic modelling for design and evaluation of metabolic
engineering strategies
tativ
5. Characterize metabolic flux map through the catabolic pathways in microbes and propose
relevant metabolic engineering strategies
PO1 PO2 PO3 PO4

e
6. detail cellular modifications of metabolic, gene regulatory, and signalling
processes/networks to achieve enhanced production of metabolites including
pharmaceuticals, biochemicals and other biotechnology products.
Course
CO - PO mapping
PO5 PO6
outcomes
CO1 3 1 2 2
CO2 3 2 2
CO3 2 2 2 2 2
CO4 2 1
CO5 3 1 1
CO6 2 1 2 2
REFERENCES
1. Christiana D. Smolke, “ The Metabolic Pathway Engineering Handbook
Fundamentals”, CRC Press Taylor & Francis Group, 2010.
2. Cortossa, S., Aon, M.A., Iglesias, A.A. and Lloyd.D., “An Introduction to Metabolic
and Cellular Engineering”, 2ndEdition,World Scientific Publishing Co, 2011
3. Curran, C.P., “Metabolic Processes and Energy Transfers - An Anthology of Current
Thought”, The Rosen Publishing group, Inc., 2006.
4. Nielsen, J., Villadsen, J. and Liden, G., “Bioreaction Engineering
Principles”,3rdEdition, Springer, 2011
5. Stephanopoulos, G.N., Aristidou, A.A. and Nielsen.J., “Metabolic Engineering - Principles
and Methodologies”, Elsevier Science, 2001.
PHARMACOGENOMICS L T P C
3 0 0 3
COURSE OBJECTIVES:
Upon successfully completing this course, students will:
• Describe the fundamental concepts of pharmacogenomics.
• Recognize how new technologies, such next-generation sequencing, are affecting the
development and use of pharmacogenomics.
• Aware of the significance of pharmacogenomics and its use in clinical practise.
UNIT I PHARMACOGENOMICS AND PERSONALIZED MEDICINE 9

Historical aspects of Pharmacogenetics, Pharmacogenetics and Populations, Monogenic and
Multigenic Variations of Drug Responses, personalized medicine, strategies for application of
pharmacogenomics to customize therapy, Barriers, Future Perspectives.
UNIT II PHARMACOGENETICS OF ENZYMES AND RECEPTORS 9

Pharmacogenetics of two clinically important polymorphic enzymes, CYP2D6 and TPMT, nuclear
receptors, cell surface receptors, Future Perspectives on the Pharmacogenetics of Drug Metabolism,
Nuclear Receptors, Cell Surface Receptors.
UNIT III PHARMACOGENETICS OF DRUG TRANSPORTERS 9

Organic anion and cation transporter polypeptide family – OATP-B, OATP-C, OATP-8, OATP-D,
OATP-E, OATP-F, OATP-H, OATP-I, OATP-J, and PGT OAT1, OAT2, OAT3; OCT1, OCT2, OCT3,
Ten
PepT and MRP families- MDR1, MDR3, BSEP, MRP1, MRP3, MRP4, MRP5, MRP6, MRP8 BCRP
protein.
UNIT IV
tativ
TECHNOLOGIES IN PHARMACOGENOMICS 9
Single Nucleotide Polymorphism, SNP Analysis Technologies, Biochemistries, Hybridization-Based
Approaches - Enzyme-Based Approaches, Combined Hybridization/Enzymatic Approaches, Detection
Methods, Platforms
UNIT V PHARMACOEPIGENETICS
e
General principles of epigenetic regulation – epigenetic mechanisms, DNA methylation, methylated
9
cytosine binding proteins, histone modifications, coordination of epigenetic machinery, epigenetic

functions, genetic imprinting, x inactivation, geneome defence, epigenetics and human disease -
therapeutic applications – HDAC inhibitors, DNMT inhibitors, CpG Oligonucleotides and Immune
Response, Designer Transcription Factors
TOTAL: 45PERIODS
COURSE OUTCOMES
The students will be able to
 Differentiate how individual genetic variations affect drug therapy outcomes, as well as
therapeutic efficacy and toxicity.
 Describe how single nucleotide polymorphism functions as a biomarker for the assessment of
disease, therapeutic response, and prognosis.
 As new tools based on genetics become available, use them, manage them, and decide on the
best course of action.
 Use pharmacogenomics approaches to address issues in pharmaceutical care by using a
specific pharmacological therapy.
 Be aware of the ethical and societal ramifications of genetic testing and the individualised
pharmacological therapy that results from it.
 Recognize the effectiveness of different medications based on genetics and apply it to clinical
research.
TEXTBOOKS
1. Pharmacogenetics: An Introduction and Clinical Perspective" edited by Joseph S. Bertino, et
al. 2013.
2. Concepts in pharmacogenomics. Martin M. Zdanowicz. Bethesda, Md. American Society of
Health-System Pharmacists, 2010.
3. Genomics and Pharmacogenomics in Anticancer Drug Development and Clinical Response
Beverly A. Teicher, Federico Innocenti, Springer, USA, 2008.
4. Gene-Environment Interactions: Fundamentals of Ecogenetics Costa, LG and Eaton DL.,
Wiley Press, 2006.
REFERENCES
1. Pharmacogenomics Werner Kalow, Rachel F Tyndale, Urs A Meyer, Marcel Dekker Inc., USA,
2001.
2. Pharmacogenomics in Drug Discovery and Development Second Edition Edited by Qing Yan
PharmTao, Santa Clara, Springer New York, 2014.
3. Pharmacogenomics Challenges and Opportunities in Therapeutic Implementation second
edition Edited by Y. W. Francis Lam Stuart A. Scott. Academic Press, 2019.
4. Pharmacogenomics in clinical therapeutics edited by Loralie J. Langman and Amitava
Dasgupta, John Wiley & Sons, Ltd, 2012.
CO – PO MAPPING
Course
Ten PO1
PHARMACOGENOMICS
PO2 PO3 PO4 PO5 PO6
outcomes
CO1
CO2
3
tativ 3
2
2
CO3
CO4
CO5
CO6
3
3
2
3
2
e 3
3
SEMESTER I
ELECTIVE II
NANOBIOTECHNOLOGY L T P C
3 0 0 3
COURSE OBJECTIVES:
The course aims to
 provide fundamental concepts in nanomaterials and their use with biocomponents to
synthesize and address larger systems.
 provides perspective for students who are interested in nanoscale physical and biological
systems and their applications in medicine.
UNIT I INTRODUCTION TO NANOSTRUCTURES 9

Carbon Nanotubes (CNT), Fullerenes (C60, C300) Nano Peapods Quantum Dots and Semiconductor
Nanoparticles, Metal-based Nanostructures (Iron Oxide Nanoparticles), Nanowires, Polymer-based
Nanostructures (Dendrimers), Gold Nanostructures:(Nanorods, Nanocages, Nano shells)
UNIT II PROTEIN-BASED NANOSTRUCTURES 9
Nanomotors: Bacterial (E. coli) and Mammalian (Myosin family), Nano biosensors: Science of Self-
assembly - from Natural to Artificial Structures (Biological Nanomotors - Biologically Inspired Hybrid
Nanodevices) . Engineered Nanopores.
UNIT III NANOSTRUCTURES FOR ANALYTICS 9

Nanoparticles for Electrochemical Bioassays - Luminescent Semiconductor Quantum Dots in Biology -
Nanoscale Localized Surface Plasmon Resonance Biosensors - Cantilever Array Sensors for
Bioanalysis and Diagnostics - Bio nanoarrays
UNIT IV 3-D BIO -PRINTING (THREE-DIMENSIONAL BIO-PRINTING) 9

Introduction - History, principle and its components, Classification of 3D bio-printing techniques -
Extrusion-based bio-printing, Droplet-based bio-printing, Laser-based bio-printing, Design
Requirements for 3D Bio-printing- Magnetic Resonance Imaging, Computed Tomography, Computer-
Aided Design Based Systems, 3D modelling software, Bio inks for 3D bio-printing - Applications of 3D
Bio-printing and future trends.
UNIT V NANOMEDICINE AND NANOSENSING 9

Promising nanobiotechnologies for applications in medicine – Liposomes in nanomedicine –
Therapeutic applications of nanomedicine – Nano- Sized carriers for drug delivery and drug carrier
systems – Protein and peptide nanoparticles, DNA based nanoparticles, Lipid matrix nanoparticles for
drug delivery – Design and development of bionanosensors using DNA, enzymes – Nanobiosensors
COURSE OUTCOMES:
Ten
for imaging and diagnosis.
TOTAL: 45 PERIODS
1. understand varied nanostructures
tativ
2. understand protein-based nanostructures
3. explore the nanotechnology for bioanalysis and diagnostics
1
e
4. understanding of most recent advances in Nanobiotechnology with novel Techniques.
5. know nano-based drug delivery and nanomedicine
6. explain the interaction between biomolecules and nanoparticle surface and its applications
Course outcome
CO-PO Mapping
2 3 4 5 6
CO 1 understand varied nanostructures 2 1
CO 2 Understand protein-based nanostructures 1 2 1
CO 3 Explore the nanotechnology for bioanalysis and 2 1 1 1
diagnostics
CO 4 Understanding of most recent advances in 2 1 3 2 1 3
Nanobiotechnology with novel Techniques.
CO 5 know nano-based drug delivery and 1 2 3 1 1 3
nanomedicine
CO6 explain the interaction between biomolecules and 1 2 1 1
nanoparticle surface and its applications
REFERENCES:
1. Nanobiotechnology: Concepts, Applications and Perspectives, Christ of M. Niemeyer (Editor),
Chad A. Mirkin (Editor) , Wiley-VCH; 1 edition, 2004.
2. Nanobiotechnology II More Concepts and Applications Edited by Chad A. Mirkin and Christof
M. Niemeyer. Wiley-VCH; 1 edition, 2007.
3. Nano Biotechnology: BioInspired Devices and Materials of the Future by Oded
Shoseyovand Ilan Levy, Humana Press; 1 edition 2007.
4. 3D Bio-printing -Fundamentals, Principles and Applications, Ibrahim T. Ozbolat, Academic
Press, (2016).
5. 3D Bio-printing in Regenerative Engineering, Principles and Applications, Ali
Khademhosseini, Gulden Camci-Unal, 1st edition, CRC press, (2018).
6. Bio-Nanotechnology Concepts and applications. Madhuri Sharon, Maheshwar Sharon, Sunil
Pandey and Goldie Oza, Ane Books Pvt Ltd, 1 edition 2012
APPLIED BIOPHARMACEUTICS AND PHARMACOKINETICS L T P C

3 0 0 3
COURSE OBJECTIVES:
 To learn the principle parameters involved in drug absorption and disposition
 To understand the concepts of bioavailability and bioequivalence of drug products and
their significance
 To understand the pharmacokinetic parameters and its application as clinical
pharmacokinetics
UNIT I BIOPHARMACEUTICS IN DRUG ABSORPTION AND DISTRIBUTION 9
Ten
Mechanisms of drug absorption through GIT, factors influencing drug absorption though GIT,
absorption of drug from Non-per oral extra-vascular routes, Distribution of drugs, Tissue permeability
of drugs, binding of drugs, apparent volume of drug distribution, plasma and tissue protein binding of
tativ
drugs, factors affecting protein-drug binding. Kinetics of protein binding, Clinical significance of protein
binding of drugs.
UNIT II BIOPHARMACEUTICS IN ELIMINATION
e
affecting renal excretion of drugs, renal clearance, Non- renal routes of drug excretion of drugs
UNIT III BIOAVAILABILITY AND BIOEQUIVALENCE

Definition and Objectives of bioavailability, absolute and relative bioavailability, measurement of
9
Drug metabolism, metabolic pathways, factors affecting metabolism, renal excretion of drugs, factors
bioavailability, in-vitro drug dissolution models, in-vitro-in-vivo correlations, bioequivalence studies,

methods to enhance the dissolution rates and bioavailability of poorly soluble drugs.
UNIT IV PHARMACOKINETICS 9
Introduction to Pharmacokinetics, Pharmacokinetic models, One compartment open model
Intravenous Bolus Injection – Intravenous infusion - Extra vascular administrations. Determination of
pharmacokinetics parameters and their significance - Absorption Rate Constant (ka), Elimination Rate
Constant (K) & Elimination Hal- life (t½), AUC, Cmax, and tmax. Apparent Volume of Distribution (Vd)
& Renal Clearance (Q).
UNIT V CLINICAL PHARMACOKINETICS AND NONLINEAR PHARMACOKINETICS 9

Altered kinetics in pregnancy, child birth, infants and geriatrics. kinetics in GI disease, malabsorption
syndrome, liver, cardiac, renal and pulmonary disease states. Concept, Accumulation, Persistent and
elimination factors. Calculation of dosage regimen following repetitive IV and oral administration.
Nonlinear Pharmacokinetics - Introduction, factors causing Non-linearity, Michaelis-menton method of
estimating pharmacokinetic parameters.
TOTAL: 45 PERIODS
COURSE OUTCOMES:
The student will be able to
 Explain the various factors influencing the drug disposition, various pharmacokinetic parameters
 Design and interpret the bioavailability and bioequivalence of dosage forms.
 Identify the factors affecting the rate of drug absorption.
 Know about clinical pharmacokinetics
 Recognize the application of pharmacokinetics
 Be familiar with applications of Biopharmaceutics.
CO – PO MAPPING
APPLIED BIOPHARMACEUTICS AND PHARMACOKINETICS
CO 1 3 3 2 1 1 -
CO 2 3 3 2 1 1 -
CO 3 3 3 2 1 1 -
CO 4 3 3 2 1 1 -
CO 5 3 3 2 1 1 -
CO 6 3 3 2 1 1 -
REFERENCES:
Ten
1. Shargel,L and Andrew, B.C. Yu. “Applied Biopharmaceutics & Pharmacokinetics”,7th Edition,
The McGraw-Hill Companies, Inc, 2016.
Edition, Vallabh Prakashan, 2015.

tativ
2. Brahmankar, D.M. and Jaiswal, S.B. “Biopharmaceutics and Pharmacokinetics: a Treatise” ,3rd
3. Chatwal, G.R. “Biopharmaceutics and Pharmacokinetics”, 2nd Edition, Himalaya Publishing
e
House, 2014.
4. Rosenbaum, S. E. “Basic Pharmacokinetics and Pharmacodynamics: An Integrated Textbook
and Computer Simulations”, 2 nd Edition, John Wiley & Sons, 2016.
5. Gibaldi, M. “Biopharmaceutics & Clinical Pharmacokinetics”, 4th Edition, Pharma Book
Syndicate, 2016.
6. Jambhekar, S.S. and Philip, J. B. “Basic Pharmacokinetics” 2nd Edition, Pharmaceutical
Press,2012
MOLECULAR MEDICINE L T P C
3 0 0 3
COURSE OBJECTIVES:
 To provide an in-depth analysis of molecular medicine and mechanisms of diseases
associated with Cardiac, renal endocrine and Nephrons.
UNIT I MOLECULAR BASIS OF DISEASES 9

Concepts pertaining to the Molecular basis of Infectious disease and metabolic disorders.
Human genetics relevant to molecular medicine, single nucleotide polymorphisms, multiple
gene polymorphisms, single and multi-gene diseases, gene-environment interactions in
disease manifestation, genetic and physical mapping of human genome and identification of
diseases gene.
UNIT II MOLECULAR BASIS OF GENETIC DISORDERS 9

Single-Gene Disorders, Autosomal Dominant Disorders -Polycystic Kidney Disease,
Marfan’s Syndrome, Huntington’s Disease . Autosomal Recessive Disorders-Cystic Fibrosis,
Phenylketonuria, Gaucher Disease, Ichthyosis, Tay–Sachs Disease.
UNIT III BACTERIAL INFECTIONS, ANTIBIOTIC ACTION AND DRUG

RESISTANCE 9
Principles of Microbial Pathogenesis, Molecular basis of infection and pathogenesis of
Bacillus anthracis, Mycobacterium spp., Mechanism of bacterial persistence and survival,
Ten
Immunological response of Mycobacterial infection, Antibiotic action and resistance
mechanisms, Drug resistance - origin (genetic and non-genetic), mechanisms.
tativ
UNIT IV MOLECULAR VIROLOGY 9
Molecular basis of Dengue infection and pathogenesis, molecular biology of Hepatitis A, B,
C, D & E, and virulence, molecular Biology of HIV Infection, Influenza Virus, Measles,
Mumps, Chicken Pox, Poliomyelitis, Human Papilloma virus (HPV), Rabies, Yellow fever and
UNIT V MOLECULAR DIAGNOSTICS

e
and Japanese Encephalitis. Anti-viral chemotherapy and viral vaccines.
PCR-Based Methods for Mutation Detection, Alternative Methods for Mutation Detection and
DNA Sequencingfor Disease Association, Microarray Approaches to Gene Expression
Analysis, Methods for Analysis of DNA Methylation, Other Clinical Diagnostic
9
Technologies:Flow Cytometry, Medical Cytogenetics, Fluorescence In Situ Hybridization,

Immunohistochemistry, Laser Capture Microdissection (FFPE).
TOTAL: 45 PERIODS
COURSE OUTCOMES:
Upon successful completion of this course a students will be able to:
1. explain the organizational requirements for the translation of biomedical therapeutics
from bench to bedside.
2. debate the impact translational research has had on human health and disease.
3. explain why pharmaceutical companies select particular drug or therapeutic targets for
further study.
4. articulate the significance and potential of molecular medical advances in biomedical
research.
5. apply the knowledge to decipher the mechanisms of molecular and cell biology.
6. synthesize the ideas for the improvement in the current technology.
CO Vs PO mapping
outcomes
CO1 3 1 2 2
CO2 3 2 2
41
CO3 3 2 2 2
CO4 3 1
CO5 3 1 1
CO6 3 1 2 2
REFERENCES:
1. Jameson, J. L., Francis, S.C., “Principles of Molecular Medicine”, Human Press, 1998.
2. Ross, D.W. “Introduction to Molecular Medicine”, 3 rd Edition, Springer, 2002.
3. Elles, R., Mountfield, R. (2011). Molecular Diagnosis of Genetic Diseases. Springer
Publication..
4. Pasternak, J.J. “An Introduction to Human Molecular Genetics”, 2 ndEdition, Wiley Liss,
2005.
5. Strachan, Tom and Andrew P. Read. “Human Molecular Genetics, Bios, 1996.
BIOGENERICS AND BIOPHARMACEUTICALS L T P C

3 0 0 3
COURSE OBJECTIVES:
 Introduce the students about biogenerics and biosimilars and their characterization
using analytical methods.
 Correlate the conceptual learning of biopharmaceuticals with their therapeutic
Ten
equivalence using case studies..
UNIT I BIOGENERICS INTRODUCTION 9
tativ
Definition: Generics and its advantages; Biogenerics and Biosimilars; why biosimilars are
not (bio) generics; The advent of Biosimilars; The role of patents in the drug industry;
Protein-based biopharmaceuticals; Manufacturing processes; Global market; International
Non-proprietary Names (INN) nomenclature system biosimilars regulation (EU position, US
pathways, Government initiatives)
UNIT II BIOSIMILARS AND ITS SCENARIO e

Approved follow-on proteins/Biosimilars; Characteristics of high selling peptides and
9
proteins,; Products with expired patents; Challenging originator’s patents; Target products
for FOB (follow-on biologics) /Biosimilars development peptides; Recombinant Non
Glycosylated proteins; Recombinant glycosylated proteins; Industries dealing with
biogenerics and its market value; World scenario; Indian scenario.
UNIT III CHARACTERIZATION OF BIOSIMILARS 9

Approaches to the characterization of biosimilars; Problems in characterizing
biologics(Types of biologic, Peptides, Non-glycosylated proteins, Glycosylated proteins,
Monoclonal antibodies); Equivalence issues; Post-translational modifications; Effect of
microheterogeneity; Pharmacokinetics; Pharmacodynamics; and Clinical efficacy; Analytical
Methods for the characterization of biosimilars (Chromatography, Protein sequencing, Mass
Spectrometry, UV absorption, Circular dichroism, X-ray techniques, Nuclear magnetic
resonance, Electrophoresis, Western blotting, Bioassays, ELISA, Immunoprecipitation and
other procedures)
UNIT IV IMMUNOGENICITY OF BIOPHARMACEUTICALS 9

Immunogenicity of biopharmaceuticals: Immunogenicity; Factors contributing to
immunogenicity, (product-related factors and host-related factors), consequence of
immunogenicity to biopharmaceuticals; Measurement of immunogenicity.
42
UNIT V CASE STUDIES
Case Studies: Erythropoietin, Insulin, Somatotropin, Interleukin-2, Interferon, Granulocyte-
macrophage-CSF, DNase, Factor VIIa, Factor IX, Factor VIII, Activated protein C, Tissue
plasminogen activator, Monoclonal antibodies etc., Immunogenicity of biopharmaceuticals:
Immunogenicity; Factors contributing.
TOTAL : 45 PERIODS
COURSE OUTCOMES:
At the end of the course the student will be able to
1. Acquire knowledge about biogenerics, biosimilars, their nomenclature and regulations.
2. Update the patent and market scenario of follow on proteins.
3. learn about the characterization of biosimilars.
4. Attain the knowledge of immunogenicity of biopharmaceuticals
5. Have exposure on case studies dealing with immunogenicity of biopharmaceuticals
6. Apply the knowledge of biopharmaceuticals regulations, characterization and it
Immunogenicity properties
CO - PO mapping
outcomes
CO1 3 3
CO2
CO3 3 1 3 1
Ten
CO4 3 2 1
CO5 3 2 1
CO6 3 1 3 1
REFERENCES:
tativ
1. Niazi, Sarfaraz K. “Handbook of Biogeneric Therapeutic Proteins: Regulatory,
Proteins andGenes into Drugs”, 2nd edition, 2013. e

Manufacturing, Testing, and Patent Issues”. CRC Press, 2006.
2. Ho, Reedney J. Y., MiloGibaldi. “Biotechnology & Biopharmaceuticals ransforming
3. S. Lakshmana Prabu, TNK. Suriyaprakash, “Intellectual Property Rights”, InTech,

Croatia, 2017.
4. Sarfaraz K. Niazi, Handbook of Biogeneric Therapeutic Proteins: Regulatory,
Manufacturing, Testing, andPatent Issues, CRC Press, 2006.
5. Rodney J Y Ho, MILO Gibaldi, Biotechnology & Biopharmaceuticals Transforming
proteins and genes intodrugs, 1stEdition, Wiley Liss, 2003.
6. Prugnaud, Jean-Louis, Trouvin, Jean Hugues. “Biosimilars” Springer, 2012
7. Shein-Chung Chow. “Biosimilars: Design and Analysis of Follow-on Biologics” CRC
Press, 2013.
ENVIRONMENTAL BIOTECHNOLOGY L T P C
3 0 0 3
COURSE OBJECTIVES
 To study the environmental biotechnology is to understand the current applications of
biotechnology to environmental quality evaluation, monitoring and remediation, of
contaminated environments.
UNIT I CONCEPTS OF ENVIRONMENTAL BIOTECHNOLOGY 9

Definition, Historical background, scope applications of biotechnology. Biosorption - use of
bacteria, fungi and algae in biosorption. Biodegradation of polychlorinated hydrocarbons.
43
Biodegradation of Pesticides. Microbial treatment of oil pollution. Genetically engineered
organisms – Merits and demerits – Bio tools for environmental monitoring.
UNIT II BIOTECHNOLOGY AND VALUE ADDITION 9

Bio processes in waste treatment - Production of value added products from waste – single
Cell Protein (SCP), ethanol, methane and hydrogen, amino acids, vitamins -Enzyme
production from wastes – Biodegradable plastics - Environmental implications -
.Biotechnology of Microbial composting - Biofertilizers- Biopesticides.
UNIT III BIOMEDICAL WASTE AND ITS MANAGEMENT 9

Biomedical waste: Introduction: definition, Classification, types and composition, Types of
solids, liquids, sharps, blood and blood tissue, radioactive material, biological and chemical
material. Documentation of Biomedical waste types and guidelines. Storage of hospital
waste; Types of bags and containers used for storage; Segregation of biomedical waste into
different type; Handling and transport of hospital waste. Transport of medical waste:
Authorization and accidental spilling reporting.
UNIT IV ENVIRONMENT AND HEALTH 9

Concept, indicators and determinants of health- Bioindicators –Biomarkers –Biosensors –
Biomonitoring. Environmental hazards-physical, chemical, biological, sociological &
psychological. Concept, causation and natural history of disease. Principles of environmental
control. National health policy and health situation in India
UNIT V
Ten
ENVIRONMENTAL IMACT ASSEMENT
Environmental Impact Assessment (EIA): Concepts, objectives, origin & generalised
9
tativ
approach to EIA. Methodologies of EIA and EIA guidelines (GOI Notification of 1994, 2006).
Environmental Impacts, their types & important impacts to be considered in EIA .
Environmental Impact Statement & Environmental Management Plan. Environmental
Auditing: Concept & guidelines.
COURSE OUTCOMES:
At the end of the course the student will be able to
e TOTAL : 45 PERIODS
1. summarise biodegradation of polychlorinated hydrocarbons, pesticides through

genetically engineered organisms.
2. illustrate bio processes in waste treatment and its end products
3. segregate biomedical waste into different type.
4. detail biomonitoring system in securing human health.
5. learn environmental impact assessment techniques.
6. recognise the environment and different processes that take place on Earth.
CO - PO mapping
outcomes
CO1 3 3
CO2 3
CO3 3
CO4 3
CO5
CO6 3 3 3
REFERENCES:
1. Alcamo, I.E.(1994). Fundamentals of Microbiology. The Benjamin/Cummings Pub. Co.,
USA.
2. Kumar, R. (1987). Environmental Pollution & Health Hazards in India. Ashish Pub.
44
House, New Delhi.
3. Abbasi, S.A. & Ramasami, E. (1999). Biotechnological Methods of Pollution Control.
Unviersities Press (India) Ltd., Hyderabad.
4. Baldwin, J.H. 1985. Environmental Planning & Management. International Book
Distributors. Dehradun, India.
5. Chatterji. A.K., 2003. Introduction to Environmental Biotechnology. Prentice Hall of
India Pvt. Ltd., New Delhi.
METABOLIC PROCESS AND ENGINEERING L T P C

3 0 0 3
COURSE OBJECTIVES:
 This course aims to provide fundamental and advanced knowledge in the development
of microbial strain for bio production through metabolic engineering.
UNIT I CELLULAR METABOLISM 9

Transport Processes – Fueling reactions – Glycolysis, fermentative pathways – TCA
cycle and oxidative phosphorylation, anaplerotic pathways –Catabolism of fats, organic
acids, and aminoacids - Biosynthesis of aminoacids, nucleic acids, and fatty acids –
Polymerization – Growth energetics.
Ten
UNIT II REGULATION, MANIPULATION AND SYNTHESIS OF METABOLIC
PATHWAY 9
Regulation of enzyme activity – Regulation of enzyme concentration – Regulation of
metabolic networks – Regulation at the whole cell level – Metabolic pathway
tativ
manipulations – Enhancement of Product yield and productivity – Extension of substrate
range, product spectrum and novel products (Antibiotics, Polyketides, Vitamins) –
Improvement of cellular properties – Metabolic pathway synthesis algorithm – Lysine
biosynthesis.
UNIT III ANALYSIS AND METHODS FOR THE METABOLIC FLUX

e
Metabolic flux map – Fluxes through the catabolic pathways in microbes– Metabolic flux
analysis for determined, over-determined and under-determined systems –Sensitivity
9
analysis – Direct flux determination from fractional label enrichment – Applications involving
complete enumeration of metabolite isotopomers – Carbon metabolite balances-GC-MS
for metabolic flux analysis – genome wide technologies
UNIT IV GENOME BASED METABOLIC MODEL DEVELOPMENT 9

Development of Genomic scale metabolic model, Insilico Cells:studying genotype-phenotype
relationships using constraint-based models, case studies in E. coli, S.cerevisiae metabolic
network reconstruction methods, optimization of metabolic network, Identification of targets
for metabolic engineering; software and databases for genome scale modeling
UNIT V ANALYSIS OF METABOLIC CONTROL AND INDUSTRIAL CASE

STUDIES 9
Fundamental of Metabolic Control Analysis (MCA), MFA, and MPA and their application,
Multi- substrate enzyme kinetics, Metabolic engineering examples for bio-fuel, bio-plastic and
green chemical synthesis , Study of genome scale model in various systems for the
production of green chemicals using software tools
TOTAL: 45 PERIODS
COURSE OUTCOMES:
45
1. highlights the engineering of the biology of microbes for maximal metabolite
production.
2. summarize the cellular transport process, Regulation of enzyme activity and
metabolic pathway synthesis algorithm.
3. acquire foundational technical knowledge of the production of biosynthetic products
through recombinant DNA technology.
4. implement genome-scale metabolic modelling for design and evaluation of metabolic
engineering strategies
5. Characterize metabolic flux map through the catabolic pathways in microbes and
propose relevant metabolic engineering strategies
6. detail cellular modifications of metabolic, gene regulatory, and signalling
processes/networks to achieve enhanced production of metabolites including
pharmaceuticals, biochemicals and other biotechnology products.
CO - PO mapping
outcomes
CO1 3 1 2 2
CO2 3 2 2
CO3 2 2 2 2 2
CO4 2 1
CO5 3 1 1
Ten
CO6 2 1 2 2
REFERENCES
tativ
1. Christiana D. Smolke, “ The Metabolic Pathway Engineering Handbook
Fundamentals”, CRC Press Taylor & Francis Group, 2010.
2. Cortossa, S., Aon, M.A., Iglesias, A.A. and Lloyd.D., “An Introduction to
Metabolic and Cellular Engineering”, 2ndEdition,World Scientific Publishing Co, 2011
e
3. Curran, C.P., “Metabolic Processes and Energy Transfers - An Anthology of
Current Thought”, The Rosen Publishing group, Inc., 2006.
4. Nielsen, J., Villadsen, J. and Liden, G., “Bioreaction Engineering
Principles”,3rdEdition, Springer, 2011
5. Stephanopoulos, G.N., Aristidou, A.A. and Nielsen.J., “Metabolic Engineering -
Principles and Methodologies”, Elsevier Science, 2001.
SEMESTER II
ELECTIVE III
BIOINFORMATICS AND COMPUTATIONAL BIOLOGY L T P C
3 0 0 3
COURSE OBJECTIVES:
 To get familiarized with protein three dimensional structure, modeling, docking and
molecular dynamics simulations
 Understand basics concepts in Machine learning, Systems Biology approaches and
informatics techniques for protein identification
UNIT I GENOME BIOINFORMATICS 9

Automatic analysis, alignment, comparison and annotation of biological sequences; analysis
of genome evolution and variation; molecular biology databases.
UNIT II PROTEIN STRUCTURE, MODELLING AND SIMULATIONS 9
46
Protein Structure Basics, Visualization, Prediction of Secondary Structure and Tertiary
Structure, Homology Modeling, Protein Protein Interactions, Molecular Docking principles
and applications, Molecular dynamics simulations.
UNIT III PHARMACOINFORMATICS 9

Molecular library management and virtual screening, computer assisted drug design and
quantitative modelling of structure-activity relationships (QSAR and 3D-QSAR)
UNIT IV BIOMEDICAL COMPUTING 9

Clinical and healthcare information systems, biomedical imaging analysis, studying
genotype-phenotype relationships and IT support systems for healthcare decision making.
UNIT V MACHINE LEARNING, SYSTEMS BIOLOGY AND OTHER

ADVANCED TOPICS 9
Machine learning techniques: Artificial Neural Networks Applications in Protein secondary
structure prediction, Hidden Markov Models for protein and gene families, Introduction to
Systems Biology, Biological networks : Protein interaction and Gene regulatory networks and
network motifs Single Input Module, Dense Overlapping Regulon and Feed Forward Loops,
Microarrays and Clustering techniques for microarray data analysis, Informatics techniques
for analysis of Mass spectrometry data : protein identification.
TOTAL: 45 PERIODS
COURSE OUTCOMES:
Ten
1. summarise the basic procedures involved in genome assembly and annotation.
2. understand concepts in biological sequence analysis, next generation
tativ
sequencing data
analysis.
3. domonstrate the utility of molecular docking and simulations and analyze the results.
4. Illustrate machine learning techniques, networks in Systems biology, microarray data
analysis and interpretation of results.
structure of bio-molecules and their biological activity.

e
5. possess competence to unveil the relationship between the three-dimensional
6. have proficiency to handle macromolecular data of sequence and three-dimensional

coordinates
CO - PO mapping
outcomes
CO1 3 1 2 2
CO2 3 2 2 1
CO3 2 2 2 2
CO4 1 3 1 1
CO5 3 1 1
CO6 2 1 2 2
REFERENCES:
1. David W. Mount. Bioinformatics - Sequence and Genome Analysis. Cold Spring
Harbor Laboratory Press, New York
2. Finkelstein A, Ptitsyn O. Protein physics: a course of lectures. 2nd ed Academic
Press. 2016.
3. PHILIP E. BOURNE Structural Bioinformatics / edited by Philip E. Bourne, Helge
Weissig Hoboken, N.J. : Wiley-Liss, C 2003
4. TAYLOR, W. R. (Willie R.). Protein Geometry, Classification, symmetry and topology:
a computational analysis of structure / William R. Taylor and András Aszódi Bristol:
47
Institute of Physics Pub., Once. 2005.
5. Leach, A. Molecular Modelling: Principles and Applications. 2a. ed. Harlow: Pearson
Education, 2001.
Ten
tativ
e
48
BIOPROCESS ENGINEERING AND TECHNOLOGY L T P C
3 0 0 3
COURSE OBJECTIVES:
 Gain knowledge about the design of production of bioproducts under aerobic and
anaerobic states, process economic and preparation of flow sheet of production
process.
 State the enzyme kinetics, various factors regulating catalysis, different models for
analyzing the enzyme kinetics, Immobilization and large-scale production of enzyme;
UNIT I BLACK BOX MODEL 9

Yield coefficients, black box stoichiometries, elemental balances, heat balance, degrees
of reduction balances, systematic analysis of black box stoichiometries, and identification of
gross measurement errors
UNIT II DESIGN OF FERMENTATION PROCESSES 9

Kinetics of substrate utilization, biomass growth and product formation, inhibition of cell
growth and product formation. Design and operation of continuous cultures, chemostat in
series, batch and fed batch cultures, total cell retention cultivation.
UNIT III MODELING OF VARIOUS FERMENTATION PROCESSES 9

Principles of model building for biotechnological processes, unstructured models on the
population level, structured models on the cellular level, morphologically structured model,
Ten
genetically structured models, cybernetic model, modeling of recombinant systems.
UNIT IV BIOREACTOR DESIGN & CONSTRUCTION 9
tativ
Basic design and construction of CSTR, bioreactor design of agitator / agitator motor, power
consumption in aerated bioreactor, design of sparger, mixing time estimation, oxygen
mass transfer capability in bioreactor, Removal of Heat in bioreactor, Main parameters to
be monitored and controlled in fermentation processes.
UNIT V CASE STUDIES IN FERMENTATION DERIVED PRODUCTS

e
Case studies on Production of green chemicals, algal biofuels, recombinant Insulin. Case
studies on medium design, reactor design & process optimization.
COURSE OUTCOMES:
TOTAL: 45 PERIODS
9
Upon successful completion of this course the students will be able to:
1. Develop the capacity of production processes and control of aerobic and anaerobic
systems, solve calculation based on process economy as well as to recognize the
importance of flow sheet of the production system
2. Explain the kinetics of enzyme catalysed reaction in free and immobilized states.
3. organise the production of microbial enzymes and operate variables affecting the
production process.
4. demonstrate about concept and criteria of scale up of laboratory process,
Instrumentation and process control- offline and online.
5. Collect the proficient knowledge of translation of lab data to pilot level, they will be able
to solve features involved in the scale up process, process monitoring and control.
6. plan a research career or to work in the biotechnology industry with strong foundation
about bioreactor design and scale-up.
CO - PO mapping
outcomes
CO1 2 2 3
CO2 3 2 3
49
CO3 3 3
CO4 3 3 2 3
CO5 3 2 3
CO6 2 3
REFERENCES:
1. Shuler, M.L., Kargi F., “Bioprocess Engineering – Basic Concepts “,
Prentice Hall, 2nd Edition, 2015.
2. Pauline D., “Bioprocess Engineering Principles “. Elsevier, 2nd Edition, 2012.
3. Nielsen, J. and Villadsen, J. “Bioreaction Engineering Principles”. Springer,
3rd Edition, 2011.
4. Lydersen B.K., “Bioprocess Engineering Systems, Equipment and
Facilities” , WileyBlackwell, 2nd Edition, 2010.
5. Bailey, J.E. and Ollis, D.F. “Biochemical Engineering Fundamentals", 2nd
Edition, McGrawHill, 2017.
6. Stanbury, P.F., Stephen J.H., Whitaker A., “Principles of Fermentation
Technology”,Science & Technology Books, 2nd Edition, 2009.
Ten
MOLECULAR PHARMACOLOGY L T P C
3 0 0 3
COURSE OBJECTIVES:
tativ
 know the basic molecular mechanism of drug action, receptors and their mode of
action, endogenous bioactive molecules, drugs acting on various systems, toxicology
applicable in drug discovery.
UNIT I MOLECULAR MECHANISM OF DRUG ACTION
e
Basic concepts in molecular pharmacology: agonists, antagonists and inverse agonists;
10
potency, intrinsic activity and efficacy; Transducer mechanisms of receptors; Receptor

occupancy theory and cellular signalling systems such as G-proteins, cyclic nucleotides,
calcium and calcium binding proteins, phosphatidylinositol. Ion channels and their
modulators: measurement of binding and response, Voltage-gated ion channels. G protein-
coupled receptors, G proteins and effectors, Mechanism of G protein-mediated signalling: -
Wnt, hedgehog and notch; Signal transduction through tyrosine kinases; Receptors
regulating gene expression.
UNIT II RECEPTORS AND THEIR MODE OF ACTION 8

Angiotensin receptors Excitatory amino acid receptors Kinin receptor, Adrenoceptors, Low
molecular weight heparins, hirudins and GP IIB/IIIa receptor antagonists, Cholinergic
receptors, Dopamine receptors, Serotonin receptors, Hormone receptors, GABA and
Benzodiazepine receptors, Opioid receptors, Purinergic receptors, Glutamate receptors.
UNIT III BIOACTIVE MOLECULES 8

Endogenous bioactive molecules: Cytokines, neuropeptides and their modulators,
neurosteroids, nitric oxide, phosphodiesterase enzyme and protein kinase C, arachidonic
acid metabolites, COX- 2 regulators and their role in inflammation, endothelium derived
vascular substances (NO, endothelins) and their modulators.
50
UNIT IV OVERVIEW OF DRUGS ACTING ON VARIOUS SYSTEMS 10
Central nervous system, Autonomic nervous system, Autacoids, Analgesic, Antipyretic, and
Anti-inflammatory Agents, Renal and cardiovascular system, Anti Infective agents,
Hormones, Hematopoietic agents.
UNIT V TOXICOLOGY 9
Principles of toxicology, Physicochemical, Biochemical and genetic basis of toxicity,
principles of toxicokinetics, mutagenesis and carcinogenesis, Acute, sub-acute and chronic
toxicity studies according to guidelines. Guidelines and regulatory agencies – CPCSEA,
OECD, FDA, ICH, FHSA, EPA, EEC, WHO.
TOTAL: 45 PERIODS
COURSE OUTCOMES:
1. To describe basic concepts in molecular pharmacology of several agonists:
antagonists transducer mechanisms of receptors and receptors regulating gene
expression.
2. To illustrate various receptor mechanism required for drug discovery Process.
3. To detail endogenous bioactive molecules and neuro transmitters essential for drug
development procedure.
4. To highlight drugs acting on Central nervous system, Autonomic nervous system to
understand the mechanism of drug action.
5. To explain the principles of toxicology, guidelines and regulatory agencies –
CPCSEA, OECD, FDA, ICH, FHSA, EPA, EEC, WHO.
Ten
6. To summarize various applications of drugs in human health care and safety
regulations
CO Vs PO mapping
Course
outcomes
PO1
tativ
PO2 PO3 PO4 PO5 PO6
CO1
CO2
CO3
CO4
CO5
CO6
2
3
3
3
2
2
3
2
2
2
1
2
2
2
1
e 2
2 2 2 2
REFERENCES:
1. Laurence Brunton, Bjorn Knollmann, RandaHilal-Dandan, “Goodman and Gilman’s:
The Pharmacological basis of therapeutics”, McGraw-Hill Education / Medical, 13th
edition, 2017.
2. Tripathi, K.D. “Essentials of Medical Pharmacology”, Jaypee Brothers Medical
Publishers, 8 th edition, 2018.
3. RS Satoskar Nirmala Rege SD Bhandarkar, “Pharmacology and
PharmacoTherapeutics”, Elsevier India, 26 th edition, 2020.
4. Francesco Clementi (Editor), Guido Fumagalli (Editor), “General and Molecular
Pharmacology: Principles of Drug Action”, Wiley, 1st edition, 2015.
5. Karen Whalen, “Lippincott Illustrated Reviews: Pharmacology”, Lippincott Williams
and Wilkins, 7th Edition, 2019.
6. James Ritter, Rod Flower, Graeme Henderson, Yoon Kong, Loke David, Mac Ewan
Humphrey Rang “Rang and Dales Pharmacology”, Elsevier, 9 th edition, 2018.
7. Katzung, B.G., “Basic and Clinical Pharmacology”, 14th Edition, McGraw Hill 2017.
51
BIOCONJUGATE TECHNOLOGY L T P C
3 0 0 3
COURSE OBJECTIVES:
 At the end of the course, the student would have learnt about enzymes, nucleic
acids and how to modify them for target specificity. Student also gets familiarized
with the industrial applications of this technology.
UNIT I FUNCTIONAL TARGETS 9

Modification of Amino Acids, Peptides and Proteins – Modification of sugars,
polysaccharides and glycoconjugates – modification of nucleic acids and
oligonucleotides.
UNIT II CHEMISTRY OF ACIVE GROUPS 9

Amine reactive chemical reactions – Thiol reactive chemical reactions – carboxylate reactive
chemical reactions – hydroxyl reactive chemical reactions – aldehyde and ketone reactive
chemical reactions – Photoreactive chemical reactions.
UNIT III BIOCONJUGATE REAGENTS 9

Zero length cross linkers – Homobifunctional cross linkers – Heterobifunctional cross linkers
– Trifunctional cross linkers – Cleavable reagent systems – tags and probes.
UNIT IV ENZYME AND NUCLEIC ACID MODIFICATION AND CONJUGATION 9

Properties of common enzymes – Activated enzymes for conjugation – biotinylated enzymes
Ten
– chemical modification of nucleic acids – biotin labeling of DNA- enzyme conjugation to
DNA – Fluorescent of DNA.
UNIT V
tativ
BIOCONJUGATE APLICATIONS
Preparation of Hapten-carrier Immunogen conjugates - antibody modification and
conjugation – immunotoxin conjugation techniques – liposome conjugated and derivatives-
9
COURSE OUTCOMES:
e
Colloidal –gold-labeled proteins – modification with synthetic polymers.
TOTAL : 45 PERIODS
1. Acquire the knowledge of modifying functional agents such as proteins, sugars, etc.,
2. Apply the knowledge of chemical reactivity of active groups
3. Know about the conjugate reagents
4. Attain the knowledge of enzyme and nucleic acids modification and conjugation
5. Have the knowledge of bioconjugate applications
6. Apply the knowledge of bioconjugate and its applications
CO - PO mapping
outcomes
CO1 3 1 3 2
CO2 3
CO3 3 1
CO4 3 1 1
CO5 3 2 2 1
CO6 3 1 3 2
REFERENCES:
1. Chemistry of bioconjugates : synthesis, characterization, and biomedical
applications / edited by Dr. Ravin Narain, Department of Chemical and
Materials Engineering, University of Alberta, Edmonton, Alberta, Canada.
52
2. Hermanson, G.T. “Bioconjugate Techniques”. Academic Press 3rd edition, 2013.
3. Sam Massa and Nick Devoogdt (eds.), Bioconjugation: Methods and Protocols,
Methods in Molecular Biology, vol. 2033, Springer Science Business Media,
LLC, part of Springer Nature 2019.
4. Sonny S. Mark (ed.), Bioconjugation Protocols: Strategies and Methods,
Methods in Molecular Biology vol. 751, DOI 10.1007/978-1-61779-151-2_1,
Springer Science+Business Media, LLC 2011.
5. Chrostof M.Niemeyer (Eds) Methods in Molecular Biology. 283. Bioconjugation
Protocols Strategies and Methods. Humana Press.
SEMESTER II, ELECTIVES IV

BIO-ENTREPRENEURSHIP L T P C
3 0 0 3
COURSE OBJECTIVES:
The main objectives of this course are to:
 enable the students to understand the sources of innovation opportunities and
development of the skills to identify and analyze these opportunities for
bioentrepreneurship and innovation.
specific
Ten
 develop personal skills set for creativity, innovation and entrepreneurship and
 concepts and tools for combining and managing creativity in organization
UNIT I
tativ
BASICS OF BIOENTREPRENEURSHIP
Introduction to bioentrepreneurship – Biotechnology in a global scale, Scope in
9
e
Bioentrepreneurship, Importance of entrepreneurship. Meaning of entrepreneur, function of
an entrepreneur, types of entrepreneur, and advantages of being entrepreneur. Innovation –
types, out of box thinking, opportunities for Bioentrepreneurship. Entreprenuership
development programs of public and private agencies (MSME, DBT, BIRAC, Startup and
Make in India).
UNIT II MANAGEMENT, ACCOUNTING AND FINANCE 9

Management principles of Henry Fayol. Business plan preparation: business feasibility
analysis by SWOT, socio-economic costs benefit analysis, Sources of financial assistance –
making a business proposal, approaching loan from bank and other financial institutions,
budget planning and cash flow management, basics in accounting practices - balance sheet,
P&L account, double entry book keeping, and estimation of income, expenditure and Income
tax.
UNIT III KNOWLEDGE CENTRE AND R & D 9

Knowledge centers - Universities, innovation centre, research institutions and business
incubators. R&D - technology development and upgradation, assessment of technology
development, managing technology transfer, industry visits to successful bio-enterprises,
regulations for transfer of foreign technologies, quality control, technology transfer agencies,
UNIT IV MEDIUM & SMALL SCALE INDUSTRY 9

Definition, characteristics, need and rationale, objectives, scope and advantages of small
scale industries. Types of bioindustries – Pharma, Agri and Industry. Biofertilizers production
- Azospirillium, Azolla, Cyanobacteria and its applications. Biopecticides production -
Bacterial, fungal, viral and plant insecticides. Sericulture. Apiculture. Dairy farming. Single
Cell Protein Production and applications.
53
UNIT V MARKETING AND HUMAN RESOURCE DEVELOPMENT 9
Assessment of market demand for potential product(s) of interest, Market conditions,
segments, prediction of market changes, identifying needs of customers including gaps in
the market. Branding issues, developing distribution channels – franchising policies,
promotion, advertising, branding and market linkages. Marketing of agro products.
Recruitment and selection process, leadership skills, managerial skills, organization
structure, training, team building and teamwork.
TOTAL: 45 PERIODS
COURSE OUTCOMES:
On the successful completion of the course, student will be able to:
1. know the legal and financial conditions for starting a business venture
2. explain the importance of marketing and management in small businesses venture
and can interpret their own business plan
3. identify the elements of success of bioentrepreneurial scheme and projects
4. Can able to specify the basic performance indicators of various entrepreneurial
activities.
5. Summarise the regulations for transfer of foreign technologies
6. Student will be able to analyse the business environment in order to identify business
opportunities.
CO - PO mapping
outcomes
CO1
Ten
1 1 2 2 3
tativ
CO2 1 2 2 3
CO3 1 2 2 3
CO4 1 1 3
CO5 1 1 2 3
CO6
REFERENCES
3 1 2 2
e
1. Principles of Management”, PC Tripati, PN Reddy,–Tata Mc Graw Hill
2. Management Fundamentals”, Robert Lusier – Concepts, Application, Skill
Development” Thomson
3. Entrepreneurship Development” S S Khanka , S Chand & Co
4. Dynamics of Entrepreneurial Development & Management” Vasant Desai Himalaya
Publishing House
BIOMATERIALS AND TISSUE ENGINEERING L T P C

3 0 0 3
COURSE OBJECTIVES:
The objective of this course is to
 Acquire knowledge on biomaterials and its applications
 Enable the students to learn the aspects of tissue engineering
 Get information about the applications of tissue engineering
UNIT I BIOMATERIALS 9
Biomaterials: Properties of biomaterials-Surface, bulk, mechanical and biological- Scaffolds
& tissue engineering - Types of biomaterials-biological and synthetic materials- Biopolymers-
Applications – Modifications – Nanotechnology in biomaterials.
54
UNIT II BASIC BIOLOGY OF STEM CELLS 9
Stem Cells: Introduction- hematopoietic differentiation pathway -Potency and plasticity of
stem cells- Stem Cell markers- Types and sources of stem cell with characteristics:
embryonic- adult- haematopoietic- fetal- cord blood-placenta- bone marrow-primordial germ
cells- cancer stem cells.
UNIT III TISSUE ENGINEERING 10

Introduction to tissue engineering: Basic definition-current scope - cell numbers and growth
rates- measurement of cell characteristics –morphology- number viability- motility and
functions. Measurement of tissue characteristics - appearance- cellular component-ECM
component- physical properties.
UNIT IV TISSUE REPAIR 8

Tissue types and Tissue components, Tissue repair and Engineering -wound healing and
sequence of events - Cell-Matrix- Cell-Cell Interactions - telomeres and Self renewal-
Control of cell migration in tissue engineering.
UNIT V CLINICAL APPLICATIONS AND ETHICAL ISSUES 9

Stem cell therapy-Molecular therapy - In vitro Organogenesis-Neuro degenerative diseases-
spinal cord injury- heart disease- diabetes- burns and skin ulcers- muscular dystrophy-
orthopaedic applications - Patent protection and regulation of tissue engineered products-
ethical issues.
COURSE OUTCOMES:
Ten TOTAL: 45 PERIODS
tativ
Upon completion of this course, the students would get
1. Awareness about the properties and broad applications of biomaterials
2. Overall exposure to the role of tissue engineering and stem cell therapy in
organogenesis
3. Knowledge of tissue engineering principles
e
4. Ability to understand the tissue components and tissue repair
5. Opportunity to get familiarized with the stem cell characteristics and their relevance
in medicine
6. to know the applications of Biomaterials and Tissue Engineering
CO – PO MAPPING
BIOMATERIALS AND TISSUE ENGINEERING
CO 1 3 3 2 - 1 -
CO 2 3 3 2 - 1 -
CO 3 3 3 2 - 1 -
CO 4 3 3 2 - 1 -
CO 5 3 3 2 - 1 -
CO 6 3 3 2 - 1 -
REFERENCES:
1. Bernhard O.Palsson, Sangeeta N.Bhatia, ”Tissue Engineering” Pearson Publishers
2009.
2. Meyer, U.; Meyer, Th.; Handschel, J.; Wiesmann, H.P. Fundamentals of Tissue
Engineering and Regenerative Medicine. 2009.
3. R. Lanza, J. Gearhart et al (Eds), Essential of Stem Cell Biology, Elsevier Academic
press, 2006.
55
4. J. J. Mao, G. Vunjak-Novakovic et al (Eds), Translational Approaches in Tissue
Engineering & Regenerative Medicine” Artech House, INC Publications, 2008
5. Bernard N. Kennedy (editor), Stem cell transplantation, tissue engineering, and
cancer applications, New York: Nova Science Publishers, 2008.
6. Raphael Gorodetsky, Richard Schäfer Stem cell- based tissue repair, Cambridge:
RSC publishing, 2011.
ADVANCES IN OMICS SCIENCES AND TECHNOLOGY L T P C

3 0 0 3
COURSE OBJECTIVES
The course aims to,
● Provide advanced theoretical knowledge on the organization and function of
genome
● Understand the principles of functional genomic analyses
● Have knowledge on the advanced methods and approaches in proteomics.
UNIT I MICROARRAYS IN GENOMICS 9

Microarrays, types, Designing and production of microarrays; cDNA microarray technology;
Ten
Oligonucleotide arrays; Sample preparation, labeling, hybridization, generation of microarray
data. Transcriptomics using cDNA and oligonucleotide arrays.
UNIT II
tativ
NEXT GENERATION SEQUENCING TECHNOLOGIES
Overview of Next Generation Sequencing (NGS) technologies; Principles of NGS by
9
Roche/454, Illumina, Life Technologies, Pacific Biosciences, Ion Torrent technologies;
UNIT III PROTEIN MICROARRAYS AND YEAST TWO-HYBRID SYSTEM

e
Applications of NGS to disease diagnosis and personalized medicine.
Types of protein arrays; Protein microarray fabrication; Experimental analysis of proteins

9
arrays. Data acquisition and processing; Applications of protein microarray types. Principles
and methods in yeast two-hybrid system, Advances in yeast two hybrid system and its
applications.
UNIT IV TWO-DIMENSIONAL GEL ELECTROPHORESIS OF PROTEINS 9

Sample preparation, First-dimension IEF with IPG; Second dimensional separation of
proteins; Image analysis of 2-DE gels; DIGE, Protein expression profiling and comparative
proteomics of complex proteomes using 2-DE.
UNIT V MASS-SPECTROMETRY 9
Basics of Mass-spectrometry (MS) and bimolecular analysis; Common ionization methods
for peptide/protein analysis; Principles of Time of Flight (TOF), Ion Trap (IT), and Orbitrap
mass analyzers; Mass spectrometry based proteomics: MALDI-TOF, Nano-LC-MS; Gas-
chromatography coupled to Mass spectrometry; Mass-spectrometry analysis of Post-
Translational Modifications of proteins.
TOTAL: 45 PERIODS
COURSEOUTCOMES:
 Understand the designing and application of microarrays in genomics.
 Have knowledge in next generation sequencing technologies and their use in
diagnosis and personalized therapy.
56
 Have exposure to protein analysis using high end technology
 Acquire the knowledge of 2D gel Electrophoresis of proteins
 Understand the concepts of mass spectrometry in protein analysis
 Attain the knowledge of micro array , sequencing, 2D gel electrophoreses and mass
spectrometry techniques in proteins and genomics
CO - PO mapping
outcomes
CO1 3 1 2 2
CO2 3 2 2
CO3 3 2 2 2
CO4 3 1
CO5 3 1 1
CO6 3 1 2 2
REFERENCES:
1. Schena M. (2000) DNA Microarrays - A Practical Approach. Oxford University
Press.
2. Rinaldis E. D. and Lahm A (2007) DNA Microarrays. Horizon
bioscience.Causton,H.C.
3. Muller H. J. and Roder T. (2006) Microarrays. Elsevier Academic Press.
4.
5.
6.
Ten
Causton H. C., Quackenbush J., and Brazma A. (2004) A Beginner’s Guide.
Schena M. (2005) Protein Microarrays. Jones and Bartlett Publishers.
O’Connor C. D. and Hames B. D. (2008) Proteomics. Scion Publishing Ltd.
7.
tativ
Hoffman E. D. and Stroobant V. (2007) Mass Spectrometry – Principles
and Applications, JohnWiley & Sons Ltd.
57

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ANNA UNIVERSITY: CHENNAI 600 025

NON AUTONOMOUS COLLEGES AFFILIATED TO ANNA UNIVERSITY

PROGRAM EDUCATIONAL OUTCOMES (PEOs)

*Audit Course is Optional

PERIODS TOTAL CREDITS

PERIODS TOTAL CREDITS

SEMESTER II, ELECTIVES IV

PROFESSIONAL CORE (PCC)

PROFESSIONAL ELECTIVE COURSES (PEC)

PERIODS PER TOTAL

RESEARCH METHODOLOGY AND IPR (RMC)

UNIT I MOLECULAR SPECTROSCOPY 9

UNIT II NMR SPECTROSCOPY 9

UNIT III Ten

UNIT V ELECTROPHORESIS & IMMUNOASSAYS 9

UNIT I CHEMOTHERAPEUTIC AGENTS 9

UNIT II ANTIBIOTIC RESISTANCE AND DEVELOPMENT OF NEW THERAPEUTICS 9

UNIT III CLEAN ROOM TECHNOLOGY AND BIOSAFETY REGULATIONS 9

UNIT IV PRESERVATION OF PHARMACEUTICAL PRODUCTS 9

UNIT V MICROBIAL FERMENTATIONS 9

COURSE OUTCOMES: Ten

CO 4 Learn about various antimicrobial preservatives used in Pharmaceuticals and

UNIT I INTRODUCTION TO BIOREACTOR DESIGN AND CONSTRUCTION 9

UNIT III MODELING OF RECOMBINANT CULTIVATION ANIMAL AND PLANT CELL

UNIT IV DOWNSTREAM PROCESSING AND SEPARATION TECHNIQUES 9

UNIT I RESEARCH DESIGN 6

UNIT II DATA COLLECTION AND SOURCES 6

UNIT III DATA ANALYSIS AND REPORTING 6

and at International level.

 Attain the knowledge of product safety management.

UNIT I INTRODUCTION TO DRUG REGULATORY LAWS

UNIT III cGMPs& REGULATORY RECORDS 10

UNIT V QUALITY MANAGEMENT SYSTEMS 10

Apply the knowledge of drug regulatory laws. 1

CO 2 Acquire the knowledge of pharmacopoeia 1 1

UNIT I PROTEIN ENGINEERING 9

UNIT III PROTEOMICS 9

UNIT IV PROTEIN FORMULATION 9

UNIT V METHODS OF PROTEIN SEQUENCING 9

Programme Outcomes (PO)

UNIT III DEVELOPMENT OF IMMUNOASSAYS 10

UNIT IV VACCINE TECHNOLOGY 10

UNIT V DEVELOPMENT OF IMMUNOTHERAPEUTICS 8

R.Burton, Ivan M. Roitt, 2017

TECHNIQUES IN MOLECULAR BIOLOGY AND GENETIC L T P C

UNIT I VECTOR SYSTEMS 12

UNIT II ASSAY TECHNIQUES IN MOLECULAR BIOLOGY 12

UNIT III HIGH-THROUGHPUT DNA SEQUENCING 12

UNIT IV GENE EXPRESSION ANALYSIS 12

UNIT V GENOME EDITING TECHNOLOGIES 12

further studies in the area of genetic engineering.

5. illustrate technical know-how on versatile techniques in recombinant DNA technology.

Course Outcome Programme Outcomes (PO)

CO 1De Demonstrate the immunization methods and handling of animals

1. “Antibodies”, Cold Spring Harbour Laboratory, 1988.

SYNTHETIC METHODS FOR DRUG DISCOVERY

DISCOVERY OF DRUGS FROM NATURAL PRODUCTS

4. Identification of alkaloids in mixture by TLC.