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Strategies for CMC Excellence: Playbooks for Product Development from First in Human through Commercialization

Presented at: the IBC Antibody Development and Production Event Carlsbad, California, February 28, 2007

To streamline product commercialization and enable rapid product development, PDL and BioProcess Technology Consultants assembled Playbooks describing CMC activities from First in Human clinical trials through Late Stage development, supply chain, and commercial manufacturing. The Playbooks describe key tactics for improving and accelerating development. The creation and implementation of these Playbooks and their value in product development will be presented.