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    Biosimilar Workflow

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    lectotop
    This document summarizes the process of developing a biosimilar medicine. It begins by defining a biosimilar as a biological product that is similar to an already approved biopharmaceutical reference medicine. It then outlines the development pipeline, including exploratory research, preclinical studies, clinical development, and regulatory approval. The remainder of the document provides more detail on specific steps in biosimilar preparation, including developing a host cell, establishing a cell bank, protein production, purification, formulation, storage, and analytical testing.

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    Biosimilar Workflow

    Uploaded by

    lectotop
    161 views9 pages
    This document summarizes the process of developing a biosimilar medicine. It begins by defining a biosimilar as a biological product that is similar to an already approved biopharmaceutical reference medicine. It then outlines the development pipeline, including exploratory research, preclinical studies, clinical development, and regulatory approval. The remainder of the document provides more detail on specific steps in biosimilar preparation, including developing a host cell, establishing a cell bank, protein production, purification, formulation, storage, and analytical testing.

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    Biology

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    This document summarizes the process of developing a biosimilar medicine. It begins by defining a biosimilar as a biological product that is similar to an already approved biopharmaceutical reference medicine. It then outlines the development pipeline, including exploratory research, preclinical studies, clinical development, and regulatory approval. The remainder of the document provides more detail on specific steps in biosimilar preparation, including developing a host cell, establishing a cell bank, protein production, purification, formulation, storage, and analytical testing.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    161 views9 pages

    Biosimilar Workflow

    Uploaded by

    lectotop
    This document summarizes the process of developing a biosimilar medicine. It begins by defining a biosimilar as a biological product that is similar to an already approved biopharmaceutical reference medicine. It then outlines the development pipeline, including exploratory research, preclinical studies, clinical development, and regulatory approval. The remainder of the document provides more detail on specific steps in biosimilar preparation, including developing a host cell, establishing a cell bank, protein production, purification, formulation, storage, and analytical testing.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 9

    Biosimilar development

    What is a biosimilar
    A medicine which similar to biological biopharmaceutical
    medicine that has already been autorized
    The active substance of a biosimilar is similar to the one of
    biological /biopharmaceutical reference medicine (sugars,
    proteins, or nucleic acids or complex)
    Used in the same dose to treat the same disease
    Biosimilar in Indonesia : Kalbio, Dexa, Biofarma
    Ex: EPO (Erythropoietin untuk anemia pada pasien gagal
    ginjal)

    Development pipeline

    Exploratory

    Drug
    charaterization

    Drug candidate
    desain

    Understand
    the
    disease
    Epid data
    Identity
    antigen

    Seed
    history
    Presentatio
    n
    Route
    of
    administrati
    on

    Preclinical
    studies

    Bulk
    manufactur
    e
    Formulation
    Identity
    Purity
    Standard
    stability

    Pilot scale

    Safety
    Toxicology
    Teratology

    Clinical
    developme
    nt

    Clinical lot
    cGMP
    QC
    QS

    Regulatory
    Approval

    GCP
    Phase I
    Phase II
    Phase III

    Commercial
    manufacturin
    g

    Document

    Regulatory
    compilance
    cGMP
    QC
    QMS

    Preparation of Biopharmaceutical

    The DNA sequence and the host cell will


    significantly

    Develop host cell

    No two master cell bank are exactly


    identical

    Establish cell bank

    Protein production

    The condition of culturing can affect the nature of the


    end product

    Any change in the purification process can affect the clinical product
    charateristics

    Purification

    Storage and handling


    Formulation
    Analysis

    Poor adherence to cold storage requirements and shaking can affect clinical
    efficacy and safety
    Component and process of the formulation. Can significanly affect the product
    behavior in patients
    Analysis has limited ability to detect all product charateristic that may affect clinical
    efficacy and safety

    Process in Biosimilar : Research scale


    Upstrea
    m

    Start

    Downstre
    am

    Analysis

    Gen sequence

    MCB

    Harvest

    Chemical/physi
    cal

    Vector

    Fermentation

    Capture

    Biology

    Host cells

    Enzyme process

    Intermediet
    purification

    Polishing

    Process in Biosimilar : Start gene design

    Sintetic gene
    Conventional Gene isolation

    Vector cloning
    Vector expression

    Mamalian
    Bacteria
    Yeast

    Upstream : research scale

    Upstrea
    m

    MCB

    Fermentation

    Sintetic gene/ conventional Gene isolation,vector


    cloning, expression test
    MCB characterization, MCB storage
    Mammalian,yeast, bacteria : media, growth
    factor
    Fermentor and bio-reactor
    Secondary Metabolism detector

    Downstream : research scale

    Downstre
    am

    Harvest

    Capture

    Centrifuge, TFF (Tangensial flow filtration), direct filtration


    Microfluidic, French Press, sonicator
    Chromatography system
    Chromatography resin

    Enzyme process

    Trypsin, or protease
    Conventional Gene isolation

    Intermediet
    purification

    Chromatography system
    Chromatography resin

    Polishing

    Chromatography system
    Chromatography resin

    Analysis

    Analysis

    Chemical/physi
    cal

    Biology

    Primary, secondary, tertier and quartenary structure


    LC-MS/MS
    DLS
    CD
    Binding assay : ELISA or SPR
    In vitro assay
    Endotoxin test
    Host cell DNA /protein residual
    Isoelectric focusing
    Western blot

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