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.
Read the full story here: https://www.biocompare.com/Editorial-Articles/358606-Perspectives-on-Pilot-Plants/