Scaling up research procedures into clinical-scale manufacturing of new cellular therapeutics presents a challenge for many academic facilities. In this webinar, Drs. Adrian Gee and David McKenna will describe some of the considerations faced when translating cell therapy research to the clinic. Topics covered will include: 

  • The product development process; from proposal to development, through validation, and ultimately to clinical use
  • Reagents and materials to be used, including culture systems and automated devices
  • The team members needed for successful translation of manufacturing methods
  • Development of release testing criteria, financial considerations, and the impact of FDA regulations

Featured Speakers

Adrian P. Gee, PhD

Director, GMP Facilities, Center for Cell and Gene Therapy
Baylor College of Medicine

Dr. Adrian Gee is director of the GMP Cell Processing and Vector Production Core Facilities at the Center for Cell and Gene Therapy at Baylor College of Medicine. His research interests include cellular therapy, stem cell transplantation, and regulatory issues and quality assurance. He is a co-founder of the International Society for Cell and Gene Therapy.

David McKenna, MD

Medical Director of Molecular and Cellular Therapeutics (MCT)
University of Minnesota

Dr. McKenna is a Professor in Laboratory Medicine & Pathology at the University of Minnesota.  He holds the American Red Cross Chair in Transfusion Medicine, and he serves as the Director of the Division of Transfusion Medicine and Medical Director of Molecular and Cellular Therapeutics (MCT), the University’s cGMP facility.


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