September 20, 2023
Gillette Stadium

<< Back to Agenda

Session 2: Microbiome Therapeutics CMC Considerations

2:00 PM – 2:45 PM | East Red Level, Suite 10

This presentation will explore bioprocessing unit operations, analytical methods, and quality perspectives for microbiome therapeutics. Specifically, attendees will learn;1) Differences between donor derived products and cultivated (fermented) microbiome therapeutic products 2) Standard unit operations for starting material, drug substance, and drug product processing for donor derived and cultivated products 3) Standard analytical methods used for testing donor derived and cultivated products 4) Multi-product facility manufacturing considerations for microbiome therapeutics.

Speaker: William Zile, Senior Manager, Seres Therapeutics

William (Billy) Zile is currently the Senior Manager of Internal Manufacturing Sciences & Technology (MSAT) supporting clinical and commercial products. He has worked at Seres Therapeutics for the last six and a half years, supporting SER-109 from clinical through PPQ and PAI as well as supporting development and tech transfer of Phase 1 and Phase 2 cultivated products. He previously worked at Shire (now Takeda) and holds an MS in Bioengineering and BS in Chemical and Biological Engineering from Tufts University.




Sponsored by: