SES215c - 2022 FOYA Winner: Strategies for Building Next Generation Autologous Cell Therapy Facilities – A case study of Iovance Biotherapeutics Journey in building, qualifying and providing clinical patients with TIL therapy
Strategies for Building Next Generation Autologous Cell Therapy Facilities – A case study of Iovance Biotherapeutics Journey in building, qualifying and providing clinical patients with TIL therapy. Building an advanced commercial therapeutic manufacturing facility, let alone an autologous cell therapy product is extremely complex, highly customized and has many unique considerations that have to established prior to program execution. Iovance Biotherapeutics will share the challenges they faced when building a cutting-edge cell therapy manufacturing facility from site selection to build-out to operational readiness and execution. Key insights into the company’s approach to mitigating risk under accelerated timelines and through the Coronavirus pandemics will also be discussed. - Building successful project workstreams and executing under tight timelines and complex deliverables - Explain the site selection process including a “make vs. buy” business case analysis utilizing modular and single-use technology - Share insights into building out infrastructure, quality and technical systems - Learn about phased implementation, commissioning, and qualification strategies, change management, and regulatory approval processes
Senior Vice President, Commercial Manufacturing,
Iovance Biotherapeutics, Inc.
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