Transportable, Small Footprint Biopharmaceutical Manufacturing Facilities: A Regulatory Perspective
ISPE’s Transportable/Point of Care (PoC) Manufacturing Technology team, a working group under the Product Quality Lifecycle Implementation (PQLI)® committee, is presenting a session entitled Transportable, Small Footprint Biopharmaceutical Manufacturing Facilities: A Regulatory Perspective at the 2022 ISPE Annual Meeting & Expo on Monday, 31 October at 1100–1230 as part of the Manufacturing Trends track. The session, which will be moderated by Michael O’Brien, PhD, President & CEO of NGT BioPharma Consultants, will address potential financial, technical, quality, and regulatory challenges while highlighting known and anticipated opportunities associated with the transportability of autonomous manufacturing environments. Case studies will be presented to illustrate the challenges versus benefits of platform and facility mobility. Additionally, viewpoints on advanced biopharmaceutical manufacturing trends drawn from the work of the PQLI committee and Transportable/PoC Mfg Technology working group will be discussed.