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Expert Roundtable: How do we realize the full potential for Small Molecule in the new decade? Panel discussion with experts in the area of small molecule continuous manufacturing will discuss the technical, regulatory, and business hurdles for continuous manufacturing. This session will highlight CM as a continuum from E2E to hybrid approaches, including the need for "batch steps" for some products, requirement differences which can be a hindrance to global implementation of advanced technologies enabled by CM such as PAT, RTRT, and modeling; and why E2E CM may or may not be the optimal solution.
Malcolm Berry, PhD, CEO & Founder MB
Chemistry Consulting, Ltd.
Sharmista Chatterjee, PhD, Division Director OPMA,
OPQ/CDER
Gabriella Dahlgren, PhD, Manager, Strategy Deployment
Janssen Supply Group LLC
Elizabeth Grieco, Director Vertex
Michael O’Brien, PhD, Founder and President NGT
BioPharma Consultants
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…
This session will explore novel ways to reduce project time lines and demonstrate how PODular manufacturing will increase facility flexibility to meet potential future changing business needs…