CMC Struggles In CGTs: Why Manufacturing And Quality Are Critical To Meeting FDA Expectations

Recent FDA rejections of advanced cell and gene therapy (CGT) programs highlight a critical fact: Chemistry, Manufacturing, and Controls (CMC) issues remain the most significant barrier to Biologics License Application (BLA) approval. This isn't just about a manufacturing mishap; it's about foundational gaps in your strategy, which the FDA’s Complete Response Letters (CRLs) consistently flag.

In this educational session, leading CGT industry experts share their deep insight into the most common CMC pitfalls—such as inadequate potency assays, comparability failures during scale-up, or facility readiness shortcomings—that can silently derail a BLA submission. You'll gain practical, actionable knowledge on how to proactively build a robust, phase-appropriate CMC strategy. Understanding and aligning your manufacturing and quality processes with current FDA expectations is the single most effective way to improve your chance of approval and accelerate patient access to life-changing therapies.

Watch now to learn how to avoid a costly Complete Response Letter.