Capturing Manufacturing Know-How And Managing Automation Changes Across Sites
During our Cell & Gene Live, Automating Autologous CAR T Manufacturing: Lessons from Mayo Clinic, expert panelists Anthony DeFusco, M.S., Senior Director of Quality Control for the Center for Regenerative Biotherapeutics; Snigdha Rai, M.S., Senior Director of Biomanufacturing; and Cynthia Wilkins, Ph.D., M.B.A., Senior Director of Process Development and Assistant Professor of Regenerative Medicine, Mayo Clinic discussed how important manufacturing knowledge can be lost when operators' observations and process nuances are not captured in batch records or automated systems. They explored the advantages of modular platforms for academic and multi-product environments, while weighing the risks of committing to equipment that may limit future flexibility.