In this webinar Terumo BCT present two perspectives on automation in the cell therapy space featuring well known experts in the field: Dr. Bruce Levine, who discusses recent developments in CAR T cell processes and Gerhard Bauer, who discusses Viral Vector production and other recent advances in his laboratory. This thoughtful discussion will be moderated by Dr. Jim Beltzer from Terumo BCT.
Watch this On Demand webinar with our expert panel to gain insight into:
- Specific real-world experiences of implementing automation strategies, tools, and technologies at different stages in the product development life-cycle for cell and gene therapies;
- Key considerations in the implementation of automation: Resources, Processes Determining Factors, Challenges, Device Selection, Outlook on Future;
- Important manufacturing considerations to enable large-scale, quality-assured vectors for clinical use;
- Moving the conversation forward in addressing the cost-effective, scalable manufacture of CAR-T therapies, and their safety and clinical outcomes;
- An exploration into what works now, why, and what directions they would like to see the field take in the future, from our two experts in cell processing.
Bruce Levine, Director of the Clinical Cell and Vaccine Production Facility (CVPF), University of Pennsylvania
Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 3,000 cellular products administered to >1,200 patients in clinical trials since 1996. He is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr. Levine is co-inventor on 24 issued US patents and co-author of >160 manuscripts and book chapters with a Google Scholar citation h-index of 75. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. Dr. Levine is President Elect of the International Society for Cell and Gene Therapy and serves on the Board of Directors of the Alliance for Regenerative Medicine. He has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Forbes, BBC, and other international media outlets.
Gerhard Bauer, Laboratory Director, GMP Facility, UC Davis Institute for Regenerative Cures
Gerhard was born in Austria, and attended college and medical school in Vienna. He moved to the US in the late 1980s to run the HIV research laboratory at the University of Maryland at Baltimore. A few years later he accepted a job at the Johns Hopkins University and started the development of clinical stem cell gene therapy for HIV. In 1995 he moved to Los Angeles to accept a position at the University of Southern California, Children’s Hospital Los Angeles (CHLA), where he was involved in the development of clinical grade stem cell gene therapy transduction and cell processing procedures. He performed all cell processing for the clinical trials of stem cell gene therapy for HIV, including the first child in the world treated with stem cell gene therapy for HIV. It was also at CHLA where he started with the development, design and implementation of academic Good Manufacturing Practice (GMP) facilities for cellular therapies. In 2002 he was recruited to Washington University in St. Louis to build and direct a new GMP facility and center for cellular and gene therapy. The GMP facility there was soon named one of the best academic GMP facilities in the United States at that time, and attracted many visitors from the US and abroad. In 2006 he was recruited back to California, to UC Davis, to be part of the new Stem Cell Program. Here he designed and has since been directing the UC Davis GMP facility, which opened in February of 2010, again being among the best academic GMP facilities in the US. It has gone through FDA review and sign-off, and has also received excellent reviews in the major facilities grant application to the California Institute for Regenerative Medicine (CIRM). CIRM awarded 20 million dollars to UC Davis to build the UC Davis Institute for Regenerative Cures, of which the GMP facility is an integral part. The state of the art setup he created at UC Davis allows moving laboratory research with human stem cells into clinical applications, and is therefore vital in developing cures and treatments for a multitude of currently incurable diseases. Over the last 8 years, several novel manufacturing technologies for gene therapy vectors have also been pioneered in this facility. The UC Davis GMP facility currently manufactures products for six clinical trials conducted in several centers nationwide.
Jim Beltzer, Senior Cell Processing Specialist, Terumo BCT
Jim earned his Ph.D. in Biochemistry at Purdue University and did his post-doctoral fellowship at the Biocenter in Basel, Switzerland. He worked at several start-up biotechnology companies in the Boston area and at Corning Life Sciences prior to joining the Cell Processing team at Terumo BCT. He has more than twenty five years of research and development experience in a broad range of disciplines.