S38: A Novel Bacterial Contamination in Cell Culture Manufacturing

A Genentech mammalian cell culture manufacturing facility recently experienced bacterial contamination events with a novel spirochete organism never previously observed within the manufacturing network.  This organism presents unique challenges to both prevention (e.g, ability to penetrate industry-standard 0.1 um filtration) and detection (undetectable via standard microbiology methods). Thus, this experience warrants disclosure to the industry at large.  This presentation will describe the approaches taken to enhance prevention and detection, as well as the assessment of the potential for impact to drug product, should a contamination remain undetected.  Finally, potential implications for non-mammalian cell culture applications will be discussed