PHILIPPINE ASSOCIATION OF COLLEGES OF PHARMACY (PACOP)

COURSE SPECIFICATIONS

COURSE TITLE Biopharmaceuticals COURSE CODE

CREDIT UNITS 3 units COURSE REQUISITES Pharmaceutical Biochemistry,
Manufacturing Pharmacy
CONTACT ( 3 hours per week) COURSE CO- None
HOURS REQUISITES
COURSE 3rd Year, Second Semester COURSE
PLACEMENT FACILITATOR/S:
Rationale: Designed to explain the genetic manipulation of living things or their cells, including (but not limited to) proteins and monoclonal antibodies, peptides, and
other molecules that are not chemically synthesized, along with gene therapies, cell therapies, and engineered tissues.

Focus: Pharmaceutical aspects of the biological preparations in current clinical use, including production of bacterial and virus vaccines, toxoids, and analogous products
COURSE (such as allergenic extracts), serum, plasma, and other blood derivatives for human or veterinary use, other than in vitro and in vivo diagnostic substances.
DESCRIPTION
Outcomes: At the end of the course, the students are expected to demonstrate their understanding of the properties of genetically manipulated biological preparations and
their derivatives

PROGRAM LEARNING OUTCOMES YEAR LEVEL LEARNING OUTCOMES

At the end of the program, the graduate should be At the end of the second year level, the student should be able to
able to 1. explain the drug development process (how medicines including biotech products are developed, manufactured and brought to
1. practice pharmacy in a professional and ethical the market);
manner; 2. compound and manufacture quality pharmaceutical products, including cosmetic products, according to official standards,
2. provide pharmaceutical care; PhilPSP and regulatory guidelines;
3. conduct relevant research and disseminate 3. demonstrate analytical and problem-solving skills in dispensing medicines;
findings; 4. relate biological and physiological concepts to pharmacy (drugs, biotech products and diseases)
4. apply managerial and entrepreneurial skills; 6. explain alternative modalities;
5. communicate and facilitate effectively. 7. critically evaluate scientific evidences for research and decision-making;
8. apply management and entrepreneurial skills;
9. provide healthcare information to various clients;
10.demonstrate appreciation of mathematics in the context of science & technology.

Essential Learning Constructive Alignment

Week Content Standards Declarative Knowledge Functional Knowledge Intended Suggested Assessment
Program Learning Teaching/Learnin Tasks
 Learning g Activities
Outcomes (TLAs)
Outcomes

Demonstrate understanding 1. Concepts of Molecular Defining molecular PLO1 ILO1

the concepts of molecular Biotechnology & biotechnology ILO4
biotechnology Biopharmaceuticals  
Discussing the historical
background of molecular
biotechnology
 
Identifying the different types of
biopharmaceuticals
Comparing and contrasting the
different types of
biopharmaceuticals

Demonstrate understanding 2. Cytokines & Interferons Explaining interferons in: PLO1 ILO1
of different cytokines & 2.1 Biochemistry of • cancer therapy ILO4
interferons cytokines • viral hepatitis
• treatment of multiple
sclerosis
Demonstrate understanding 3. Enzymes Analyzing the concepts of PLO1 ILO1
of enzyme in therapeutics enzyme therapy ILO4
Demonstrate understanding 4. Hormones Defining the different types of PLO1 ILO1
of different types of 4.1.1 Pituitary hormone hormones ILO4
hormones and their 4.1.1.1   ILO6
applications Adrenocorticotropic Discussing the mechanism of
Hormone action of different hormones
4.1.1.2 Melanotropins  
(Melanocyte-Stimulating Explaining the concept of
Hormone) hormones in therapeutics
4.1.1.3 Lipotropins
(Enkephalins and
Endorphins)
4.1.1.4 Growth
Hormone
(Somatotropin)
 4.1.2 Gonadotropic
Hormone
4.1.2.1 Follicle-
Stimulating Hormone
4.1.2.2 Luteinizing
Hormone
4.1.2.3 Menotropins
4.1.2.3.1 Thyrotropin
4.1.2.3.2 Somatostatin
4.1.3 Placental Hormones
Demonstrate understanding 5. Blood and Blood Enumerating different types of PLO1 ILO1
of blood and blood products Products blood products ILO4
Clotting Factors   ILO6
Relating the importance of clotting
factors in therapeutics
Demonstrate understanding 6. Vaccines Explaining the importance of PLO1 ILO1
of different types of 6.1 Types of vaccines vaccines ILO4
vaccines, its components, 6.2 Components   ILO6
and its uses 6.3 Safety and potency Enumerate the various components
of vaccines and their
pharmaceutical uses
 
Differentiating the types of
vaccines
 
Discussing the mechanisms
involved in vaccines
 
Assessing the different methods for
the safety and potency of vaccines
Demonstrate understanding 7. Monoclonal Antibodies Discussing the history of PLO1 ILO1
of monoclonal antibodies monoclonal antibodies ILO4
and their applications   ILO6
Categorize the various monoclonal
antibodies according to their
pharmacological functions
 
Relating the different monoclonal
 antibodies to the pathophysiology
of inflammatory diseases (arthritis,
sclerosis, asthma)
 
Comparing the different methods
of production of monoclonal
antibodies
 
Applying monoclonal antibodies
in therapeutics
 
Explaining the mechanism of
monoclonal antibody actions
Demonstrate knowledge of 8. Cell Therapies Defining cell therapy PLO1 ILO1
the different kinds of cell 8.1.1 Stem Cell   ILO4
therapies 8.1.2. Human Cells for Distinguishing different
transplant applications of cell therapy
8.1.3 Gene Therapy  
8.1.3.1.Ribozymes Recognizing the differences
8.1.3.2 Viral between ex vivo from in vivo gene
8.1.3.3 Non-viral therapy
 
Identifying the role of gene therapy
in clinical cases
 
Listing various vectors for gene
therapy
Demonstrate familiarity of 9. Oligonucleotides Defining oligonucleotides PLO1 ILO1
the description and   ILO4
physiological functions of Summarizing the physiological
oligonucleotides functions of oligonucleotides
 
Assessing the factors that can
improve oligonucleotide stability
 
Analyzing the factors that can
improve oligonucleotide
applications in the field of
 diagnostics and therapy
Demonstrate familiarity of 10. Peptide Therapeutics Defining peptide therapeutics PLO1 ILO1
peptide therapeutics and   ILO4
their applications Recognizing the applications of
peptide therapeutics
Demonstrate knowledge of 11. Regulating Identifying proper handling and PLO1 ILO1
proper handling , storage Biopharmaceuticals regulation of biopharmaceuticals in ILO4
and regulation of 11.1 Approval and accordance with ASEAN standards
biopharmaceuticals processing of
biopharmaceuticals
11.2 Regulating biological
products
11.3 QPIRA
Demonstrate familiarity of 12. Biosimilars Defining biosimilars PLO1 ILO1
the description, concepts   ILO4
and regulatory requirements Explain the concepts of biosimilars
of biosimilars  
Discuss the regulatory
requirements of biosimilars
Learning LCD projector, Powerpoint presentations, LED TV, audio-visual materials
Resources
Basic Readings • Gad, S.C. Handbook of Pharmaceutical Biotechnology, John Wiley & Sons, Inc.
• Crommelin, D.J.A. et al. Pharmaceutical Biotechnology: Fundamentals and Applications, 3rd Ed.
Extended • Guidelines from the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use: 2000 onwards
Readings Q1A/D/E (Stability), Q2 (Validation of Analytical Procedures), Q3A (Impurities in New Drug Substances, and Q6A (Specifications) Q7 (GMP for API).
• Guide to good manufacturing practice for medicinal products Part I: PIC/S March 2014.
• Guide to good manufacturing practice for medicinal products Part II PIC/S March 2014.
• Guide to good storage practices for Pharmaceuticals. Annex 9. WHO Technical Report Series, No. 908, 2003.
• ASEAN Common Technical Documents (ACTD) and Requirements (ACTR) (2007) Guidelines on Stability, Validation, Bioavailability and Bioequivalence, Clinical
and Nonclinical Documents
• ASEAN VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS Final Draft 7.2 2013.
Course
Assessment
Course Policies
Committee PACOP
Members
Consultation
Schedule
Course Title AY/Term of effectivity Prepared by: Approved by: Page