In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Tatyana Matveeva, Ph.D., an expert in cGMP manufacturing and regulatory compliance. They discuss cell and gene therapy (CGT) manufacturing and the importance of maintaining quality unit independence within organizations, as well as some recent compliance violations at established manufacturing facilities. When it comes to CGT production, Matveeva advocates for a quality-by-design approach to protect patients and ensure compliance with regulatory requirements.
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