Upstream processes for the production of a recombinant antibody in CHO cell culture, consisting of 5 stages including cell culture expansion,  production, clarification, direct product capture and viral inactivation, were developed and scaled up for clinical manufacturing.  These processes are controlled by a set of defined process parameters with proven acceptable ranges established based on development experience.  Variability in process parameters over operating ranges may cause variability in product attributes.  This makes it necessary to determine which process parameters are considered critical in order to establish proper control strategies to ensure a consistent product quality profile.  A criticality assessment was completed to determine which process parameters are considered critical based on the impact of each parameter's operating range on a set of product quality attributes, and based upon the degree of uncertainty of the process information.  In this evaluation seventy process parameters were considered over the 5 stage upstream process.  These process parameters were evaluated for impact on twelve critical quality attributes that define the antibody product.  Through this evaluation a number of process parameters were identified to be critical based upon impact on one or more product quality attributes.

Determination of critical process parameters based upon impact on critical quality attributes of a mammalian cell culture process

243rd National Meeting (2012)

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