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    Home > Biochemistry News > Biotechnology News > Cell line development whole process optimization protocol combing

    Cell line development whole process optimization protocol combing

    • Last Update: 2022-09-14
    • Source: Internet
    • Author: User
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    Cell line development brief:
    The basis for reliable production processes
    [1] ClD as the starting point and foundation of biopharmaceutical CMC, it is crucial to build a highly expressive stable cell line suitable for production, because it largely determines the efficiency and cost
    of drug development.
    Download high-volume cloning screening, early characterization analysis and optimization, scalability, cell line stability, etc.
    Download Chinese eBook "Efficient Cell Line Development Strategies" Scan code to download now
    Continuously optimized technical processes
    Current standard procedure steps for CLD include gene cloning and initial clonal screening, clonal screening and validation analysis, cell culture and media optimization, assessment and characterization analysis, and finally cell bank building
    .
    1 Initial clonal screening - the cornerstone host cell line developed throughout the process directly affects the specific properties of the product, such as glycosylation, carboxylation, hydroxylation, amidation, etc.
    ; It may even affect half-life, immunogenicity, and biological activity
    .
    CHO(Chinese hamster ovary) CHO cell expression systems account for more than half of the proportion
    .
    There are three main reasons
    • CHO cells are used early in the production of biological drugs, have high expression, are easy to handle and operate, and have a high degree of acceptance of regulations;
    • CHO cells also have high genetic and phenotypic instabilities, and have more cell lineages, such as DG44, DXB11, CHO K1, CHO-S, etc.
    • Pathogenic viruses cannot replicate in CHO cells, so CHO cells are considered a very safe expression system
      .

    The initial cloning phase can identify cell viability as quickly as possible, and finding stable, highly productive clones from thousands of clones will lay the foundation for the subsequent process Octet® Molecular Interaction Analysis System 2 Target Protein Expression - Multi-Directional Consideration and Adjustment After selecting the appropriate expression system, the next step is to let the nucleic acid enter the cell and express the protein of interest - transfection
    • Reagent-based methods: transfection based on cationic lipids, co-precipitation of calcium phosphate, diethylaminoethyl (DEAE)-dextran/polyethyleneimide (PEI)/polymer/tree-like macromolecule-mediated technology, etc.
      ;
    • Instrument-based methods: electroporation, microinjection, laser-mediated transfection, particle bombardment, etc.
      ;
    • Virus-mediated method: Adeno-associated virus, lentivirus and other mediated gene delivery methods
      .

    When choosing a transfection method, many factors such as cell type, product expression requirements, safety, economy, process scale-up, turnaround time and regulatory requirements need to be considered
    .
    The ideal method should have high transfection efficiency, low cytotoxicity and minimal effect on normal physiology, and be easy to use and reproducible
    .
    Chemically defined cell culture media has become the gold standard for cho cell production processes today
    .
    Ambr® 15 Micro Bioreactor PlatformOctet® Unlabeled Molecular Interaction Analysis System 4Cell® XtraCHO Medium High-Efficiency Cell Line Development: High-Throughput Cell Culture and Titer Determination3 During cell screening and evaluation, modern CLD cell cultures can also accurately and efficiently identify target cells through high-throughput analysis and screening techniques, and prepare
    for downstream processes.
    In order to improve the probability of high-expression cells, a stable and high-yielding Minipool
    can be enriched by "batch sorting method".
    Panorama function 4 insufficient single-cell cloning monoclonality on the iQue® high-throughput flow cytometry IgG titer and viability analysis kit ForeCyt® software may cause problems such as differences
    in growth rate, metabolic characteristics, recombinant protein Qp stability, product quality, etc.
    Advanced techniques are needed to clone individual cells of this type of Minipool as a starting point to ensure that all cells used in production are from single cells
    .
    The monoclonal origin verification of cells on the CellCelector platform is critical to ensuring the purity and homogeneity of biopharmaceutical products, and the Octet® Molecular Interaction Analysis System needs to further validate the bioactivity, efficacy, and critical mass attributes (CQA) of biopharmaceutical products, which will provide important guidance
    for the next step of experimentation and process development.
    5 Cell Culture and Media Optimized High-Throughput, Standardized, Automated Cell Culture and Process Optimization Accelerate Cell Line Development While Achieving More Accurate Resultsambr®15 High-Throughput Micro Bioreactor System6 Evaluation and Characterization Octet®BLI SystemSummaryDownload Download Chinese eBook High-Efficiency Cell Line Development Strategies Scan code To download now-References-
    • Zhang Ailong, "Improving the Screening Efficiency of High-yield Cell Lines and Helping gene therapy, Antibody Drugs and Other Processes--Single Cell Printers (with Case Sharing)"
    • Orphan Poison Pharmacist, "CMC Cornerstone: Cell Line Development Process in Biologics Production"
    • Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing processes.
      Günter Jagschies, Eva Lindskog, Karol Łącki, Parrish Galliher.
      2018
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