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

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.