The physicochemical characteristics of therapeutic monoclonal antibodies can be important determinants of biological activity, serum half-life, and immugenicity in humans. Additionally, the stability of formulated monoclonal antibodies is an important property for consistent clinical administration. Understanding how to control specific molecular characteristics of a monoclonal antibody aids in maintaining consistent product quality and clinical efficacy. This study determined that when a monoclonal antibody was expressed through cell culture in a production bioreactor, the pH setpoint was a key determinant of the antibody charged species distribution. Additionally, it was found that when formulated, the monoclonal antibody aggregation content and aggregation rate was correlated to the production bioreactor pH control setpoint.

Production bioreactor pH setpoint controls monoclonal antibody charged species distribution and aggregation characteristics

2019 Spring National Meeting

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