June 23, 2026
BPI Theater @ BIO 2026 | San Diego Convention Center
10:45 am PT
20 minutes

Engineering Commercial Readiness: Aligning Scale, Geography, and Launch Risk
Mike Alston Jr., Executive Director of Operations

Abstract
As biologics programs approach Phase III and BLA submission, manufacturing decisions become strategic inflection points. Commercial geography, inspection exposure, and infrastructure resilience now directly influence launch timing and long-term supply continuity. This session explores how sponsors can structure scale-up, engineering batches, and tech transfer within commercial-intent systems to reduce switching risk and prevent late-stage disruption. Drawing on real-world expansion and operational design considerations, the discussion highlights how disciplined scale-up strategy and U.S.-anchored manufacturing can serve as controlled bridges from development through PPQ and commercial launch.

Presenter Bio
Mike Alston Jr. is Executive Director of Operations at Bora Biologics, where he leads cGMP commercial and CDMO manufacturing across microbial and mammalian platforms in San Diego. He oversees manufacturing, MSAT, facilities, engineering, EHS, and supply chain, aligning operational execution with clinical and commercial biologics programs. With more than 20 years of experience in regulated manufacturing environments, Mike has led large-scale capital expansions, facility design and qualification initiatives, and GMP operations supporting Phase III and commercial supply. Prior to Bora Biologics, he served as Vice President of Operations at Avid Bioservices, overseeing clinical and commercial manufacturing and technical services. Mike is recognized for building inspection-ready, resilient manufacturing systems engineered to support launch readiness and long-term supply continuity.