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Regulatory Considerations in Cell Line Selection for Production of Antibodies

This overview discusses the upstream considerations regarding regulatory authorities, product consistency, and selection criteria for cell lines used in antibody production. It covers aspects such as cell lineage, stability, and potential cell lines, emphasizing the importance of regulatory scrutiny and product uniformity.

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Regulatory Considerations in Cell Line Selection for Production of Antibodies

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  1. A Descriptive Overview&Upstream Considerations Presented by: Michael Allen Daniel Demsey Avanthi Williams

  2. Regulatory Considerations • Process Definition • Scrutinized by regulatory authorities for safety and reliability • Product Consistency • Minimal variance in biochemical properties of product

  3. Regulatory Considerations • Cell Lineage • Origin of cell line • Health of donor • Recombination methods used (viral vectors) • Cell Line Stability • Across number of generations from cell bank to finished product

  4. Cell Line Selection Criteria • Capability to produce high product titers in the selected manufacturing process • Ability to produce a consistent product with uniform characteristics • Speed at which a high yielding cell line can be obtained

  5. Potential Cell Lines • Murine Hybridoma • Human Anti-Mouse Antibody (HAMA) response • Recombinant Mouse Cells • Transformed Human Cells • EBV-transformed human lymphoblastoid cells used to produce the anti-D antibody • Prevents hemolytic disease in infants Tumour cell Antigen Antibody-producing cloned hybridomas Monoclonal antibodies Isolated/immunized antibody-forming cell Hybridomas

  6. Cell Banking • Master Cell Bank (MCB) • Cryopreservation • Enough for life of process • Working Cell Bank (WCB) • Cryopreservation • Made from MCB Inoculate

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