Establishing The Standards Of Operational Excellence To Manufacture Commercial Cell Therapies

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 members of Lonza’s operational excellence team share the secrets behind recent successes in commercializing and producing commercial cell and gene therapies.

• 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