Starting with an un-optimized process for an early stage Mab program, process improvements were investigated to improve productivity, robustness and meet quality criteria. First, media screening studies using a few commercial formulations yielded a media/feed combination that gave almost 3X increase in titer. N-1 conditions were studied to get high cell density using a batch process. Refinement of the process to modulate growth, production and quality was achieved by titrating iron. To map out understanding of the refined process, DOE’s were performed to find optima and interactions. These led to a robust process which was locked and ready for pilot and large scale confirmation. The process was scaled up successfully from ambr® 250 to 3L to 500L pilot scales. However, challenges arose with scale up to the 2000L scale and mitigation strategies to address the issues will be discussed.

Cell culture process optimization and scale up challenges for a late stage monoclonal antibody program

2019 Spring National Meeting

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