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A Descriptive Overview & Upstream Considerations

A Descriptive Overview & Upstream Considerations. Presented by: Michael Allen Daniel Demsey Avanthi Williams. Regulatory Considerations. Process Definition Scrutinized by regulatory authorities for safety and reliability Product Consistency

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A Descriptive Overview & Upstream Considerations

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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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