This case study will focus on the development of a Phase III cell culture process using chemically-defined medium for a high demand, monoclonal antibody, product. Initial process optimization efforts yielded a four-fold improvement in productivity over the platform process, primarily as a result of a pH ramp profile and modified feeding strategy. However, the drug substance was found to be more highly colored than the Phase I material, as measured by a coloration compendial method. Modifications to the basal and feed media component concentrations were studied in order to understand their potential impact on drug substance color. Multivariate studies were employed to identify optimal formulations. A trade-off between drug substance color and productivity was observed, and the final process sought to balance these two project drivers.

Balancing productivity and product quality: Efforts to reduce drug substance color while developing a high titer mAb cell culture process

245th National Meeting (2013)

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