Optimizing Upstream Biopharmaceutical Processing Through More Effective Insight and Control of Cell Culture Media and Supplement Attributes

Despite significant advances made in recent years to increase biologic yields as well as the intensity and consistency of these processes, there is still the potential for innovation in this area in order to reach more efficient production of therapeutic proteins. Finding new approaches to improve protein expression; developing more flexible, cost-effective and robust manufacturing processes that lead to higher yields; and solving the complex task of refolding proteins into their active state are among the challenges faced by the industry.

As cell culture processes are influenced by nutrients and trace elemental impurities, cell expansion steps requiring various media components can impact the overall process and result in a lower final product yield, higher amounts of product-related impurities and/or longer process time. With a better understanding of the properties of these media and supplements, process scientists can take steps to better manage the quality and consistency of their cell culture raw materials in order to minimize variability in the upstream process.

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Authors

Claudia Berrón

Senior Vice President, Business Development and Commercial Operations – Biopharma Production

Claudia Berrón, is Senior Vice President, Business Development and Commercial Operations – Biopharma Production. Berrón had two decades of experience in B2B strategic marketing covering ideation, value proposition strategies, market segmentation, marketing and sales plan, through product launch. Berrón holds an MBA degree from the University of North Carolina, Kenan-Flagler Business School, Chapel Hill, and a BA degree from Monterrey Institute of Technology in Mexico City.

Dr. Nandu Deorkar

Vice President, Research & Development – Biopharma Production

During his more than 25-year career in materials technology research & development, Dr Deorkar has worked on various aspects of chemical/polymer R&D, drug development, formulation, drug delivery technologies, process development, and technology transfer. Dr Deorkar earned his PhD in chemistry from the Indian Institute of Technology, Bombay, and his MBA from Fairleigh Dickinson University, New Jersey (USA).

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