After entering Phase 3, cell and gene therapies experience nearly five times more discontinuations or significant delays due to CMC issues than monoclonal antibodies. The highly manual processes, lack of robust analytical methods, and lack of quality standards are often the cause and pose challenges in meeting the appropriate cGMP manufacturing standards required by regulators. During this webinar, two of Lonza’s operational excellence team will share the secrets behind recent successes in commercializing and producing commercial cell and gene therapies.
Key learning points:
- Establishing the standards of everyday operational excellence for commercial manufacturing
- Harmonizing processes and methods across sites and assets
- Continuous improvement: training, re-training, and tracking to maintain and improve standards
Hui Zheng, Head of CGT Operations, Lonza Singapore
Melanie Mansbach, Head of CGT Manufacturing, Lonza Houston