Greg Hoyt featured, “Perspectives on Pilot Plants”

Greg Hoyt featured, “Perspectives on Pilot Plants”

Mar 11, 2019

Pilot plants represent a milestone in a drug’s commercial development, where drug sponsors first explore engineering, commercialization, clinical, regulatory, and process issues outside the relative safety of laboratory scale. And, as the test ground for a product’s ultimate manufacturability, pilot scale is where drug sponsors often return to de-bottleneck or to solve unanticipated production issues.

Traditionally, companies build pilot plants before they know if a drug will be approved. This uncertainty underpins critical decision-making on both pilot and manufacturing-scale capacity, the introduction of novel manufacturing technologies, implementing scaleup and scaledown strategies, and how to conduct knowledge and process technology transfer.

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Greg Hoyt Article CRBnet