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Gene Therapy Sponsors Risk Additional Work With Late-Stage Manufacturing Changes

 
• By Derrick Gingery

Commercial scale-up during Phase III trials could create labeling issues and force additional clinical trials, US FDA officials said.

pharmaceutical manufacturing
An OTP official said pre-IND teleconference requests may be converted to written response only because of the agency's growing workload in the space. • Source: Shutterstock

Gene therapy sponsors risk review problems and development delays if they attempt manufacturing changes during pivotal clinical studies.

Commercial production processes should be in place for the entire Phase III trial, said Graeme Price, Gene Therapy Branch 4 team lead, which is in the Office of Gene Therapy CMC and part of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products

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