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    • Mainta 1 651c695423030
    1. Quality & Risk

    Case study: Maintaining quality and equivalency in custom cell culture media manufacturing from development to large-scale cGMP production

    Jan. 9, 2024
    Challenges can arise when transitioning a media formulation from a non-cGMP prototype to a cGMP-manufactured product. Our case study outlines the scale-up process that was used successfully in three complex dry powder medium (DPM) projects.

    Bioprocessing risks and challenges exist between the creation of non-GMP prototype cell culture media material and its scale-up/formulation transfer to current good manufacturing practice (cGMP) production. Here we outline the process and results of a two-phase scale-up strategy that was used successfully for three complex dry powder medium (DPM) projects.

    This content is sponsored by:

    Gibco

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