Building an advanced therapeutic manufacturing facility is complex and highly customized. In this webinar, a panel of industry experts discuss the challenges faced when building a cutting-edge cell therapy manufacturing facility from build-out to operational readiness and share key insights into their company’s approach to mitigating risk under accelerated timelines.
This webinar co-hosted by Endpoints Webinar, Precision ADVANCE, and Project Farma will be moderated by Anshul Mangal (President of Project Farma and Precision ADVANCE), and feature insights from Scott Bertch (Executive Director, Clinical Site Head at Tenaya Therapeutics), John Khoury (Executive Vice President at Project Farma), Alexis Melendez (Director, Facilities & Engineering at Kite Pharma), Faraz Siddiqui (Vice President, Process Development & Manufacturing Operations at Instil Bio), and Sumit Verma (Senior Vice President, Commercial Manufacturing at Iovance).
Attendees will have the opportunity to:
- Hear from industry leaders on their unique experiences and specific approach to building an innovative cell therapy manufacturing facility
- Understand the site selection process including a “make vs. buy” business case analysis utilizing modular and single-use technology
- Set up their build for success by creating proper project workstreams
- Gain key insights into building out infrastructure and quality systems
- Learn about phased implementation, commissioning, and qualification strategies, change management, and regulatory challenges