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In episode 128, Host Erin Harris talks to Tatyana Matveeva, Ph.D., Director of cGMP Operations at George A. "Doc" Lopez, MD Laboratory for Regenerative Cell Therapy, Harvard Medical School and Massachusetts General Hospital, about leading cGMP operations within an integrated ecosystem, where manufacturing, research, and neurosurgery coexist. Dr. Matveeva highlights key operational challenges in scaling autologous therapies, particularly around technology transfer, process reproducibility, and regulatory readiness, emphasizing the need for early collaboration between research and GMP teams. Their conversation also explores rigorous approaches to chain of identity and custody, the importance of extensive simulation runs to ensure robustness, the unique sensitivities of manufacturing cells for neurological applications, and more.
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