Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
Scribd Logo
Upload

Welcome to Scribd!

  • 98 views

    Preparation Vaccine and Sera: Group: Iii

    Uploaded by

    Ainil Mardiah
    The document discusses the production process of vaccines and sera. It describes the key steps in vaccine production which include: 1) Generation of antigens through growing viruses/bacteria. 2) Isolation and purification of antigens from cells. 3) Formulation of vaccines by adding adjuvants, stabilizers and preservatives. 4) Packaging and validation of vaccines in multiple stages to ensure quality and consistency from batch to batch. Sera contain antibodies that provide immunity against specific infections. An example is snake anti-venom which is a biological product used to treat snake bites. Proper maintenance of serpentariums is important for effective antivenom production.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd

    Preparation Vaccine and Sera: Group: Iii

    Uploaded by

    Ainil Mardiah
    98 views24 pages
    The document discusses the production process of vaccines and sera. It describes the key steps in vaccine production which include: 1) Generation of antigens through growing viruses/bacteria. 2) Isolation and purification of antigens from cells. 3) Formulation of vaccines by adding adjuvants, stabilizers and preservatives. 4) Packaging and validation of vaccines in multiple stages to ensure quality and consistency from batch to batch. Sera contain antibodies that provide immunity against specific infections. An example is snake anti-venom which is a biological product used to treat snake bites. Proper maintenance of serpentariums is important for effective antivenom production.

    Original Description:

    kjbjbj

    Original Title

    Pharmaceutical Industry

    Copyright

    © © All Rights Reserved

    Available Formats

    PPTX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    The document discusses the production process of vaccines and sera. It describes the key steps in vaccine production which include: 1) Generation of antigens through growing viruses/bacteria. 2) Isolation and purification of antigens from cells. 3) Formulation of vaccines by adding adjuvants, stabilizers and preservatives. 4) Packaging and validation of vaccines in multiple stages to ensure quality and consistency from batch to batch. Sera contain antibodies that provide immunity against specific infections. An example is snake anti-venom which is a biological product used to treat snake bites. Proper maintenance of serpentariums is important for effective antivenom production.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    98 views24 pages

    Preparation Vaccine and Sera: Group: Iii

    Uploaded by

    Ainil Mardiah
    The document discusses the production process of vaccines and sera. It describes the key steps in vaccine production which include: 1) Generation of antigens through growing viruses/bacteria. 2) Isolation and purification of antigens from cells. 3) Formulation of vaccines by adding adjuvants, stabilizers and preservatives. 4) Packaging and validation of vaccines in multiple stages to ensure quality and consistency from batch to batch. Sera contain antibodies that provide immunity against specific infections. An example is snake anti-venom which is a biological product used to treat snake bites. Proper maintenance of serpentariums is important for effective antivenom production.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 24

    PREPARATION

    VACCINE AND SERA


    GROUP : III
    • NENSI HARTATI 1511012011
    • MELISA OKTAVIA 1511012021
    • OLVI SEMARTHA 1511012023
    • FIANNY REZKA SJAHJADI 1511012027
    • ALI AKBAR 1511012029
    Biological products can be defined according to their source material and
    method of manufacture

    Biological products are derived from cells, tissues or microorganisms and reflect
    the inherent variability characteristic of living materials.

    INTRODUCTI
    ON The active substances in biological products are often too complex to be fully
    characterized by utilizing physicochemical testing methods alone and may show a
    marked heterogeneity from one preparation and/or batch to the next.

    Consequently, special considerations are needed when manufacturing biological


    products in order to maintain consistency in product quality.

    (WHO, 2016: 96)


    Vaksin adalah sedian yang mengandung zat antigenik yang mampu
    menimbulkan zat antigenik yang mampu menimbulkkan
    kekebalan aktif dan khas pada manusia. Vaksin dibuat dari bakteri,
    VACCINE risetsia atau virus dan dapat berupa suspense organisme hidup
    atau inaktif atau fraksi-fraksinya atau toksoid

    (Farmakope Indonesia Edisi IV)


    Live Attenuated virus Vaccines

    • Ex : meningitis, tuberculosis, virus measles,


    rubella

    TYPE OF Inactivated/killed virus Vaccines

    VACCINE • Ex : cbakteri kolera, pertusis, tifoid, virus


    rabies, virus influenza

    Subunit Vaccines

    • Ex : Hepatitis B, Influenza

    (Kistner, 2003)
     To produce a live vaccine, the wild or disease- causing virus is
    attenuated (weakened), traditionally by repeated culture in the
    laboratory,

    Live  The virulence properties of the virus are reduced so that it does
    not cause disease in healthy individuals. The attenuated vaccine
    attenuated virus multiplies to a limited extent in host tissue and induces an
    immune response similar to wild virus infection in the majority of
    vaccines subjects. Live vaccines are generally very effective and induce
    long-lived immunity.
     Eg. Measles, Mumps, Rubella, Varicella, Rotavirus, Tuberculosis
    (BCG)

    (Kistner, 2003)
     The term ‘killed’ is generally used for bacterial vaccines and
    the term ‘inactivated’ for viral vaccines
     These vaccines are prepared by treating the whole cell or virus
    Killed and with chemicals that cause inactivation
    inactivated  Generally these organisms remain intact and whole

    vaccines  They generate an immune response (to a broad range of antigens)


    but cannot cause an infection because they are dead and so
    cannot reproduce.
     Eg. Hepatitis A, Some influenza vaccines

    (Kistner, 2003)
     Subunit vaccines are developed using only the antigens known to
    elicit protective immunity.
    Subunit  They can be further categorised as follows
    vaccines  Eg : Hepatitis B, Influenza

    (Kistner, 2003)
    1. Raw materials, pengambilan bibit vaksin terbaik
    [virus/bakteri] agar jumlahnya memenuhi kebutuhan
    pembuatan vaksin.
    2. Cultivation & Harvest, penanaman virus/bakteri
    pada media yang sudah dimurnikan
    3. Purification, melakukan pemurnian virus/bakteri
    Proses yang sudah tumbuh, dalam proses purifikasi, yaitu
    Produksi suatu proses untuk menghilangkan zat – zat yang
    tidak reevan dengan produk vaksin.
    Vaksin 4. Formulation, memformulasikan bulk vaksin yang
    telah dimurnikan dengan zat – zat tambahan
    5. Filling, melakukan pengisian vaksin kedalam
    kemasan
    6. Packaging & Product, pemasangan label pada
    kemasan
    The production of a vaccine can be divided in the following steps:
    1. Generation of the antigen
    - The first step in order to produce a vaccine is generating the
    antigen that will trigger the immune response. For this purpose
    the pathogen’s proteins or DNA need to be grown and harvested
    Preparation of using the following mechanisms:

    Vaccines - Viruses are grown on primary cells such as cells from chicken
    embryos or using fertilised eggs (e.g. influenza vaccine) or cell
    lines that reproduce repeatedly (e.g. hepatitis A)
    - Bacteria are grown in bioreactors which are devices that use a
    particular growth medium that optimises the production of the
    antigens Recombinant proteins derived from the pathogen can
    be generated either in yeast, bacteria or cell cultures.
     2. Release and isolation of the antigen
    - After the antigen is generated, vaccines are isolated from
    the cells, used to generate it. For weakened or attenuated viruses
    no further purification may be required.
    - The aim of this second step is to release as much virus or
    bacteria as possible. To achieve this, the antigen will be separated
    from the cells and isolated from the proteins and other parts of
    the growth medium that are still present.
    - Recombinant proteins need many operations involving
    ultrafiltration and column chromatography for purification before
    they are ready for administration.
     3. Addition of adjuvants, stabilizers and preservatives
    - Once the antigen is developed the vaccine is formulated by
    adding adjuvants, stabilizers, and preservatives.
    - The role of the adjuvant is to enhance the immune response of
    the antigen.
    - The stabilizers increase the storage life.
    - Preservatives allow the use of multi dose vials.
    - Finally, all components that constitute the final vaccine are
    combined and mixed uniformly in a single vial or syringe.
     4. Packaging
    - Once the vaccine is put in recipient vessel (either a vial or a
    syringe), it is sealed with sterile stoppers.
     Validation Stage I
     Validation Stage II
     Validation Stage III
    Proses validasi  Revalidation
     Validation Studies and the WHO Pre-Qualification process
     Expectation
    • Process Description • Concentration
    • Process Characterization • Inactivation and Detoxification
    • Raw Materials / Starting • Clarification (pre-filtration)
    Materials
    • Viral clearance
    • Extractables and Leachables
    from Product-contact Surfaces • Chromatography resins and
    reusable membranes
    Validation • Seed Banks
    • Buffer preparation
    • Cell Lines and Cell Banks
    Stage I • Analytical Methods
    • Process Intermediates
    • Blending (polyvalent vaccines)
    • Validation of production Steps
    or Unit Operations • Formulation of Bulk Product
    • Propagation
    • Fermentation
    • Harvest
     Definition of Operational Parameters at commercial scale
     Manufacturing of Consistency Lots
     Consistency Lots
     Manufacturing of Clinical Phase Material
     Bracketing, Family and Matrix Validation Approach
     documentation Requirements
     personnel Training and Qualification
    Validation  Process Technology Transfer
    Stage II  Legacy products
     Design and Execution of Process Validation Studies
     Deviations Management
     Final Report
     Serum merupakan produk sebenarnya produk biologi yang sudah
    mengandung kekebalan terhadap suatu infeksi.
     Serum diberikan kepada individu bila terserang adanya infeksi
    penyakit, atau diduga akan terkena infeksi.
    SERA  Salah satu contohnya adalah serum anti bisa ular (SABU) atau
    snake anti venom merupakan produk biologis yang digunakan
    dalam pengobatan gigitan ular berbisa.
     Anti bisa ular diberikan ketika seorang pasien terbukti atau diduga
    telah digigit ular berbisa.

    (Kemenkes RI. 2016)


    • Serpentarium yang dikelola dengan baik adalah kunci dalam
    produksi antivenom dan memenuhi persyaratan kualitas untuk
    produksi yang antivenoms yang efektif.
    • persiapan referensi sangat penting, Kualitas ular yang digunakan
    untuk imunisasi hewan, sebagai bahan praklinis penilaian
    efektivitas netralisasi, atau untuk pengembangan nasional atau
    regional.
    • Prosedur yang digunakan dalam pemeliharaan ular, penanganan
    dan penambangan racun, serta dalam semua aspek pengumpulan
    racun harus didokumentasikan dan dijadwalkan dengan benar.

    WHO Guidelines for the Production Control and Regulation


    of Snake Antivenom Immunoglobulins
     Venom yang digunakan untuk preparasi antivenom
    harus mewakili seluruh populasi ular yang hidup di area
    di mana antena polispesifik dan / atau monospesifik
    dimaksudkan untuk digunakan.
     Karena variasi regional dan individu dalam komposisi
    racun dalam spesies ular, venoms yang digunakan
    untuk imunisasi harus dikumpulkan dari sejumlah besar
    individu (umumnya setidaknya 20, termasuk jantan
    dan betina dari berbagai usia) yang dikumpulkan dari
    berbagai daerah yang mencakup seluruh distribusi
    geografis dari spesies ular berbisa tertentu.

    WHO Guidelines for the Production Control and Regulation


    of Snake Antivenom Immunoglobulins
     Kontrol kualitas dari venoms ular sangat penting untuk
    memberikan jaminan bahwa venoms mewakili ular
    berbisa yang mendiami wilayah tempat antivenoms
    diproduksi.
    Quality control  Kumpulan Rumpun Referensi Nasional harus
    of venoms ditetapkan untuk mencakup setiap spesies ular yang
    penting secara medis di mana antivenom diproduksi.
     Keterlacakan setiap kumpulan racun penting untuk
    mendeteksi secara cepat setiap kesalahan yang
    mungkin terjadi selama proses persiapan.

    WHO Guidelines for the Production Control and Regulation of Snake


    Antivenom Immunoglobulins
     Untuk setiap kumpulan racun, sertifikasi yang menyatakan nama
    ilmiah spesies ular (dan subspesies jika ada), asal geografis mereka
    dan jumlah hewan yang digunakan dalam mengumpulkan bets,
    tanggal pengumpulan racun, dan lainnya yang relevan
     informasi, harus disediakan oleh pemasok racun ke produsen
    antivenom dan juga kepada otoritas pengatur jika diperlukan.

    WHO Guidelines for the Production Control and Regulation of


    Snake Antivenom Immunoglobulins
     Konsistensi (dalam batasan komposisi dan kualitas yang
    ditetapkan) kumpulan racun yang dihasilkan dari waktu ke waktu
    untuk spesies berbisa yang sama dengan asal yang sama harus
    dijamin.
     Tes khusus harus dilakukan di setiap sampel racun, dan
    datadicatat untuk dilacak, termasuk: konsentrasi protein per g
    (atau mg),
     suatupenilaian aktivitas biokimia atau biologis, pemindaian atau
    gambar dari SDS – PAGE (dalam kondisi pengurangan dan tanpa-
    reduksi), dan / atau profil kromatografi HPLC fase balik atau
    ukuran mundur dari sampel racun. Informasi ini terbukti berguna
    untuk mengkonfirmasi asal dan integritas racunnya.

    WHO Guidelines for the Production Control and Regulation of


    Snake Antivenom Immunoglobulins
    VACCINE
     Vaccine is an antigenic substance prepared from the causative
    agent of a disease or a synthetic substitute, used to provide
    immunity against one or several diseases.

    Difference  Contains dead bacteria or weak bacteria or toxins.


     stimulates the body to make antioxidants
    Between
     Gaining immunity after a period.
    Vaccines and  Remain immune for long.
    Sera  Use a series of complex methods to separate and purify the virus
    and extract the required part, reduce the low virulent or
    inactivated and produced vaccine.
     A vaccine consists of normally a single type of antibodies( usually
    monoclonal) or may be for a particular disease
    SERA
     The clear, pale yellow liquid that separates from the clot in the
    coagulation of blood
     does not contain bacteria or toxins.
     contains anti formed in another animal.
     acquired immune immediately.
     remain a short time.
     specific animal by immunization, whole blood collected in, but the
    serum is a nonspecific mixture obtained after centrifugation.
     CDC, 2014. Vaccine Storage and Handling Toolkit. Atlanta: CDC
     Departemen Kesehatan RI, Farmakope Indonesia, Edisi IV, 1995
     Kemenkes RI. 2016. Vaksin Untuk Pencegahan, Serum Untuk
    Pengobatan. www.depkes.go.id
     Kistner, Otfried, Baxter Vaccine AG, “A Novel Cell-Derived
    Influenza Vaccine, National Influenza Summit, Chicago, May 20-
    21, 2003
    Daftar pustaka  Dept. of Pharmacognosy Shri D.D Vispute College of Pharmacy
     Sugiarto. 2013. Vaksin.
     WHO Guidelines for the Production Control and Regulation of
    Snake Antivenom Immunoglobulins
     WHO. 2013.Validation of Production Processes for Vaccines for
    WHO Prequalification- Compliance Expectations :Switzerland
     WHO. 2016. WHO good manufacturing practices for biological
    products. WHO Expert Committee on Biological Standardization

    You might also like