Overcoming quality and regulatory challenges to reliably take your cell & gene therapy to commercialization

Cell and Gene Therapies (CGT) hold great promises as potentially curative medical treatments against a variety of difficult to treat diseases. However, major challenges such as scale complexity, high manufacturing cost, starting material variability need to be addressed early on in order to bring your potential life-saving therapies to patients. During this webinar, Lonza's experts will provide insights into key considerations for establishing a de-risked CGT commercialization path.

• Challenges and opportunities of autologous, allogeneic and viral vectors when considering their unique technical development & manufacturing process
• Strategies to meet the quality & regulatory requirements of CGTs
• 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

Andreas Wirth

Vice President, Global Head of Quality, Lonza

Christoph Meyer

Senior Director, Global Head Quality Control, Lonza