Author Archives: Carrie Weymer

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…