Concurrent Session: Transportable, Small Footprint Biopharmaceutical Manufacturing Facilities: A Regulatory Perspective 

Concurrent Session: Transportable, Small Footprint Biopharmaceutical Manufacturing Facilities: A Regulatory Perspective | Today’s manufacturing platforms and associated analytics are smaller, lighter, and significantly more modular versus their predecessors. These technological advances are enabling much smaller factory footprints, allowing a transportable manufacturing platform and facilities paradigm to gain considerable traction as a viable alternative to more traditional equipment train and facilities constructs. Flexible, transportable units have the potential to address variable demand through scale-out, take advantage of off-site fabrication principles, and may be installed more quickly than for traditional construction practices. Consequently, when business needs change, as they so often do, manufacturing units can be relocated.   The potential financial, technical, quality, and regulatory challenges vs. opportunities associated with the movability of the manufacturing environment will be addressed and case studies will be presented to illustrate the challenges vs. benefits of mobility and operating a mobile facility. Presentations will provide perspectives on advanced biopharmaceutical manufacturing trends drawn from the work of ISPE's Product Quality Lifecycle Implementation (PQLI)® team and subteam, ISPE PQLI Transportable/Point of Care Manufacturing Technology team.