During the Phase III clone selection and process development of a CHO-derived monoclonal antibody under an aggressive timeline, several challenges were encountered, including lower  than desired final viability and higher than desired levels of charge variants in the production culture.  Focusing on key aspects of the process and leveraging existing process knowledge, targeted cell culture studies were designed to evaluate basal media composition, batch feed number, pH and temperature shift setpoint/timing, and culture duration strategies. The studies were conducted at the 2L and 400L scale concurrently to select top clone, address process and product quality challenges, and provide material for downstream process development to enable a successful process lock for Phase III GMP campaign within twelve months. Data will be presented demonstrating this focused strategy for rapid Phase III clone selection and process development.

From clone selection to Phase III GMP in one year: A case study of efficient and targeted approach of cell cell line selection and process development for a commerical process

247th National Meeting (2014)

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