Efficient Strategies to Deliver Reliable and High Quality Biomanufacturing Processes Through Optimization of Cell Culture Media, Feeds, and Process Parameters

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FUJIFILM-ManufacturingDevelopment of a reliable and high quality biomanufacturing process for recombinant CHO cell lines presents challenges from diverse nutritional requirements observed with different clonally derived cell lines, and variable response to process operating ranges. To address these challenges, we will discuss efficient approaches to optimize CHO cell culture media, feeds, and process parameters within FUJIFILM Diosynth Biotechnologies (FDB). Also discussed is FDB’s new ApolloTM CHO expression system, a cornerstone of process scale-up efficiency offering robust gene expression in a platform media and feed production system. In this presentation, we outline efficient development strategies using informative case studies: (i) establishment of platform CHO cell culture media and feeds by implementing high-throughput media and feed development with DOE-based methodologies; (ii) demonstration of rapid optimization of media and feeds at bench scale including 2L/10L scale bioreactors; (iii) establishment of a “Toolbox” strategy targeting media, feeds, and process conditions to achieve desired mAb productivity and quality, demonstrating good process scale up.