Webinar

CMC struggles in CGTs: Why manufacturing and quality are critical to meeting FDA expectations

Recent FDA rejections of high-profile cell and gene programs underscore how CMC issues continue to be a leading barrier to approval in advanced therapy development. Learn from Cencora experts and CGT industry leaders about how proactive and strategic planning can help you get ahead of CMC roadblocks.

In this webinar, you will: 

  • Learn the most common CMC issues identified in recent CRLs
  • Uncover subtle issues that can derail your BLA submission
  • Gain insights into how you can develop a more robust CMC strategy
  • Validate processes to meet regulatory expectations and increase your chances of gaining FDA approval
     

Connect with our cell and gene therapy team

Schedule some time with our cell and gene therapy experts today. We look forward to hearing from you.

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