Author Archives: Leisha Youngblood

A Systematic Development Approach to Optimize and Control Biopharmaceutical Product Quality

The complexity of recombinant protein manufacturing processes, including expression systems, cell culture process conditions, and choice of media and feeds, present signifi-cant challenges to achieve desired product quality of bio-pharmaceuticals. To address these challenges, Fujifilm Diosynth Biotechnologies (FDB) has developed a unique systematic approach of combining “Media Toolbox” methodology, key chemical components, and cell culture bioprocess “know-how” to optimize and control manufacturing condi-tions that promote the desired product quality profiles of recombinant proteins. Case studies are presented to highlight the…

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

Development 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…