Together with product efficacy, product safety is an essential characteristic of any medicinal product including cell and gene therapy (C>) biologics. Adventitious agents (viruses, bacteria, mycoplasma, prions, etc) pose constant risk to these biologics, and, as such they may impact directly product and patient safety. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C> product manufacturing process to mitigate risk of adventitious agents. This presentation will review various interconnected steps throughout the manufacturing process, from the raw materials to the fill and finish, that would, in concert, help mitigate the risk while providing a high degree of product safety by design.

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03:00 - 04:00 hs GMT+1

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BioPharma Asia Magazine
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Control de seguridad
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  • 5 Steps to Security Validation

    20:00 - 21:00 hs GMT+1

    Fecha
    Lun 15-Jun-2020, 20:00 - 21:00 hs GMT+1
    Descripción
    Organizations have been managing security based on assumptions, hopes and best guesses for decades. We assume our technology will detect, block and send alerts, we hope our incident response techniques will be efficient and effective when under assault, and we (...)
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Mar 16 de Junio de 2020
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