Essential Strategies For Mastering CMC And Avoiding CRLs For CGTs

Cell and gene therapy (CGT) developers face mounting pressure to meet Chemistry, Manufacturing, and Controls (CMC) standards as the FDA intensifies scrutiny. Recent Complete Response Letters (CRLs) reveal recurring issues—potency assay inconsistencies, inadequate stability data, and poor process control—often stemming from the complexity of CGT products and limited regulatory precedent. Autologous therapies, in particular, challenge developers with unique batch requirements and high-touch manufacturing. To avoid delays or rejections, companies must proactively address facility readiness, data integrity, and cold chain validation. Strategic planning, early regulatory engagement, and cross-functional governance are essential to navigating these hurdles.

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