(466g) Continuous Processing Strategies for Biologics Manufacturing

There has been a growing interest in developing and implementing continuous processing for biologics manufacturing. Compared to traditional batch technologies, continuous processing offers more flexibility and can improve product quality and lower the costs of production. The US FDA has been supportive of the implementation of continuous processing using a science- and risk-based approach and there are no regulatory hurdles for its implementation. This presentation will discuss the drivers behind the rising utilization of continuous processing technologies and the challenges in development and scale up of continuous processing platforms. Case studies will be shown on developing high cell concentration perfusion cell cultures and direct product capture unit operations for manufacturing of recombinant proteins and monoclonal antibodies.