470571 Drug Product Continuous Manufacturing Control Strategy Considerations

Monday, November 14, 2016: 9:00 AM
Continental 5 (Hilton San Francisco Union Square)
Justin Pritchard, Vertex Pharmaceuticals, Boston, MA and Kelly Swinney, Pharmaceutical and Preclinical Sciences, Vertex Pharmaceuticals Inc., Bostn, MA

This presentation will cover the key components of a fully automated drug product continuous manufacturing control strategy. In-process control, real time decision making, sampling plans and sampling plan justification, and real time release testing will be discussed. Experience with filings and inspections along with a few learnings and considerations for continuous manufacturing will be shared.

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