Newsletter | February 1, 2024

02.01.24 -- Keys To Building A Successful CGT Commercial Manufacturing Operation

Secure And Industrialize Your CGT Process Toward cGMP Manufacturing

Dr. Behnam Ahmadian Baghbaderani, global head of process development for cell and gene technologies, Lonza, introduces best practices required to de-risk the commercial manufacturing of cell and gene therapies. Learn the principles of commercialization readiness and how to address logical steps in process development.

 

Keys To A Successful cGMP Manufacturing Operation Delivering CGTs

After entering Phase 3, cell and gene therapies experience nearly five times more discontinuations or significant delays due to CMC issues than monoclonal antibodies. Two members of Lonza’s operational excellence team share the secrets behind recent successes in commercializing and producing commercial cell and gene therapies.

 

Preparing For FDA Pre-Approval Inspection: Quality And Regulatory Topics

In this webinar, explore strategies to meet the quality and regulatory requirements of cell and gene therapies, and discover more about Lonza's New Product Introduction (NPI) process for CGT manufacturing, including how to identify issues early on, reduce quality and compliance risks, and avoid delays and rework.