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

Oct. 3, 2023
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.

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