Process development optimization for GMP manufacturing: A CAR-T case study

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

Process development optimization for GMP manufacturing: A CAR-T case study

Live30 webinars are thirty minute presentations designed to update you on the latest innovations, applications and data in a fast yet interactive format.

In this webinar, we will discuss the importance of PD optimization and some of the key considerations such as: choosing a partner for outsourcing PD projects, the timing needed for a typical PD project, technology and process transfer to GMP manufacturing, etc.

Finally, we will review a case study for Lentiviral manufacturing which is required upstream of an autologous CAR-T clinical trial. The duration, sequence and dependencies of these two distinct PD projects, and their subsequent GMP manufacturing campaigns, will be examined.

Understand the timing and planning process for a typical process development process to achieve GMP manufacturing.
Learn more about process development capabilities to support cGMP manufacturing.
Review a case study for Lentiviral manufacturing, supporting CAR-T.

Gary Pigeau PhD

Director of Research and Development, Nucleic Acid Therapeutics, Cytiva

Gary Pigeau received his Ph.D. in Biotechnology from Brock University in St. Catharines, Ontario. He completed a postdoctoral fellowship at the University of Alberta with a visiting scientist appointment at the University of Oxford. Gary moved to private industry in 2008, where his research group focused on process development and scale-up of a proprietary bioprocess technology. He then moved to commercial, large-scale biomanufacturing in 2013. Gary joined Cytiva, formerly part of GE Healthcare’s Life Sciences business, and the Centre for Advanced Therapeutic Cell Technologies (CATCT) at CCRM in 2016. He served until mid-2022 as the Director of the collaborative facility in Toronto, Ontario with focus on biology support for New Product Introductions, internal technology development projects and contract process development services in cell and gene therapy. Recently, Gary has taken a new role with Cytiva as Director, Research & Development for the new Nucleic Acid Therapeutics business.