In the three decades since the first biopharmaceutical, recombinant human insulin was licensed by the US Food and Drug Administration, the biopharmaceutical industry has become the fastest growing, most dynamic and technology-intensive sector in the biomedical field. To produce complex antibodies and therapeutic proteins in large quantities, mammalian cell culture remains the most demonstrated and capable option.As new developments are being made rapidly and in a competitive market, maximizing the speed to clinic and product launch becomes a primary objective. This rapid development model shifts the emphasis from late stage process development to post-launch (i.e., before reaching a product's peak demand or before transferring the process to a second manufacturing site). Also, new process requirements may challenge the previous operational paradigm and require optimization at the commercial manufacturing site. With this shift in development and operational philosophy, the need to build a more experienced and scientifically-minded technical supporting group at a commercial manufacturing site is greatly increased.Several case studies will be discussed to demonstrate the recent challenges encountered in the commercial manufacturing, including increased run rate and product mix, raw material variation, and implementation of new process requirements. Overall, the focus of commercial manufacturing is on product quality and process consistency through improved process and product understanding.

Cell culture commercial manufacturing � development and operational challenges and opportunities

247th National Meeting (2014)

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