In this final webinar of the “It’s all about manufacturing” series, eXmoor and guest speakers will focus on manufacturing considerations - with case studies covering both AAV gene therapy and autologous cell therapy products. The talks will cover the full manufacturing journey, from the tech transfer of a scaled-up process and concluding with the successful release of a product ready for patient dosing.
The speakers will discuss a variety of factors that determine a successful tech transfer from development into a manufacturing environment, including the quality management framework, documentation, training, fit-to-plant considerations and procurement. Next, the presentation will describe how to set up and operate a GMP manufacturing facility with an emphasis on quality, flexibility, and risk reduction. Finally the topics of product safety testing, batch-release and the pivotal role of QP’s will be discussed, with a special mention of the importance of partnering and outsourcing in order to maintain flexibility and speed of product release.
Key Learning Objectives
- Learn how to avoid common pitfalls when developing and executing a tech transfer plan from development into manufacturing
- Learn how to operate a manufacturing facility dedicated to Cell and Gene Therapies
- Learn how to build a phase appropriate quality system to support the GMP operations of a multipurpose facility dedicated to Cell and Gene Therapies
- Learn about the importance of partnerships in the manufacturing journey of cell and gene therapies
