Addressing Quality And Regulatory Concerns Ahead Of Pre-Approval Inspections

Andreas Wirth, Vice President, Global Head of Quality, Cell & Gene Technologies and Personalized Medicine, and Christoph Meyer, Senior Director, Global Head of Quality Control, Cell & Gene Technologies, spoke about the strategies to meet the quality & regulatory requirements of cell & gene therapies (CGT), and Lonza's New Product Introduction process (NPI) for CGT manufacturing – how to identify issues early on, reduce quality & compliance risks, and how to avoid delays and rework.