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.
Key Takeaways
- Flag the most common CMC issues cited in recent Complete Response Letters (CRLs)
- Spot subtle gaps that can derail your BLA submission
- Build a stronger, more proactive CMC strategy
- Better align your processes with FDA expectations to improve your chances of approval
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