Hard Lessons Learned Throughout A Legacy Cell Culture Process

23rd February 2021 | 10:00am EST | Presented by Ron Bates, Director at Bristol-Myers Squibb |BOOK FREE SEAT FOR THIS WEBINAR

The management of processes spanning a decade or more is complicated for many reasons, not the least of which is due to raw material variability.  There are many factors making raw material/supply chain management difficult. The reduction in the time spent in development/clinical phases results in less number of raw material lots used and hence less understanding of the potential variability in the raw material and the effect that variability has on the process. That critical dependency does not get understood until the molecule is being manufactured routinely commercially. Additionally, cell culture and fermentation media are often based on undefined or poorly defined hydrolysates which are known to vary in key components. Adding further to the raw material complexity is the fact that frequently raw materials are sourced from a single facility/manufacturer, and simple innocuous changes in their manufacturing can have disastrous results to a process. Lastly, the end supplier often has a complex supply chain themselves, and the inputs to their process could have variability that affects the drug manufacturer’s process.  This webinar will example a few key raw material-related disruptions to normal manufacturing.

Presented by Ron Bates, Director at Bristol-Myers Squibb

I lead the Manufacturing Science and Technology (MST) group at Bristol-Myers Squibb (BMS) in Syracuse, NY and am responsible for monitoring, validating, transferring, and improving late-stage and commercial manufacturing processes. Prior to BMS, I led the process development and MST group at Allergan focusing on developing, optimizing, characterizing, transferring, and support manufacturing of wild-type and recombinant prokaryotic-based systems to manufacturing. At Allergan, we developed high throughput methods and implemented disposable processing. Prior to Allergan, I worked at BMS-Syracuse developing and transferring downstream processes to manufacturing for late-stage Fc-fusion and monoclonal antibodies. Before BMS, I worked at Pfizer purifying small molecule moieties using chiral, normal phase, and reversed phase chromatography in traditional, flash, and multi-column continuous systems.  I received my Ph.D. from the University of Maryland, Baltimore County in Biochemical Engineering under Doug Frey studying mathematical modeling of ion exchange chromatography and my B.S. in Chemical Engineering from Rensselaer Polytechnic Institute.

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