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Transportable, Small Footprint Biopharmaceutical Manufacturing Facilities: A Regulatory Perspective

Michael K. O'Brien, PhD
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.

Today’s manufacturing platforms and associated analytics are smaller, lighter, and significantly more modular when compared to their predecessors. These technologically advanced systems have enabled substantially smaller platform and factory footprints that, in turn, have fueled an uptick in the design and construction of transportable single-unit operations platforms and multi-unit-operations facilities. This paradigm shift has gained considerable traction as a viable alternative to more traditional equipment train and facility constructs.

2022 ISPE Annual Meeting & Expo

Flexible, transportable units have the potential to address variable demand through scale-out, take advantage of off-site fabrication practices, and can oftentimes be installed more quickly than for traditional construction practices. Consequently, when business needs change, as they so often do, manufacturing units have the potential to be renovated, repurposed, and relocated to another on-site or off-site location.

During this 90-minute session, complementary industry perspectives from equipment/autonomous facilities providers and biopharmaceutical manufacturers will be respectively provided by Dennis Powers, Vice President, Business Development & Design Consulting, G-CON and Richard Panton, Principal Engineer, Roche/Genentech.

Thomas O’Connor, PhD, Deputy Director, Office of Testing and Research, FDA will round out the session by highlighting regulatory viewpoints on advanced manufacturing initiatives, including his sharing of output from CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative. Dr. O’Connor’s talk is quite timely, coming a couple of weeks prior to the upcoming FDA/PQRI (virtual) Workshop on the Regulatory Framework for Distributed and Point-of-Care Pharmaceutical Manufacturing on November 14 – 16 2022.

To learn more about the latest trends in transportable manufacturing and Industry and Regulatory insights on this exciting topic, please join us on Monday October 31 at 11:00 am to hear from our impressive lineup of speakers.

Richard R. Panton
Principal Engineer
Roche Genentech
Dennis Powers
Vice President of Business Development & Design Consulting
G-CON Manufacturing
Thomas F. O'Connor, PhD
Deputy Director, Office of Pharmaceutical Quality

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