enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness
“Manufacturing readiness in drug development is often underappreciated. We have already scaled detalimogene manufacturing to commercial-level, and CDRP is expected to help ensure CMC readiness for filing and commercialization,” said Ron Cooper, President and Chief Executive Officer. “Our progress on the manufacturing front is in sync with detalimogene clinical development, where we recently announced improved six-month complete response rate in the LEGEND trial pivotal cohort.”
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