Stacy Cline Amin spoke to Genetic Engineering & Biotechnology News about recent Food & Drug Administration (FDA) guidance that is addressing the challenges of manufacturing cell and gene therapy (CGT) products with a proposed draft guidance.
"Managing changes to manufacturing processes has been a common roadblock for many CGT companies to navigate, particularly given that manufacturing challenges have been pervasive in this industry," Stacy said. "CGT companies have been frustrated with written-response-only meetings and the lack of informal opportunities to consult with the agency. This guidance should reduce some of the uncertainties CGT sponsors face and help facilitate more meaningful discussions between FDA and industry on some of these nuanced quality issues."
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