Streamline Microbial Process Development to Reach GMP Faster

By Steve Loftus, PhD, Director, Commercial Technical Lead, Biologics, FUJIFILM Biotechnologies

Microbial-based fermentation can yield major benefits for patients and manufacturers in terms of accessibility and cost-effectiveness. It allows for both faster processes and notable cost-savings; that said, it comes with inherent challenges and requires expert understanding and handling. Oftentimes, microbial-based products are unique, complex molecules that require specific processes that may not be platform-based. They require specific purification techniques and specialists that can think critically to adapt approaches.