Manufacturing Autologus Ex Vivo Genetically Modified Cell Therapies have Challenges, but the Future is Bright

  • Review the supply chain
  • Examine the contributors of costs
  • Solution for industrial scale viral vector manufacturing
  • Cell processing and viral transduction hubs
  • Rapid analytics for product testing
  • Brighter future for patients with fitter cell therapies

Joseph Tarnowski
SVP, Cell & Gene Therapy, R&D Medicinal Science and Technology

Prior to his current role in CGT, Joe was the Senior Vice President of Biopharm CMC R&D. Before joining GSK in June, 2010, Joe was the Senior Vice President, Biologics Manufacturing and Process Development in the Technical Operations division of Bristol-Myers Squibb Co. in New Brunswick, NJ. Joe was responsible for building the manufacturing capabilities needed to supply the company’s biologic medicines to worldwide markets, including the construction of the company’s new $750 million large-scale multi-product bulk biologics manufacturing facility in Devens, Massachusetts, and the integration of Medarex, Inc. He has spent over 35 years in the pharmaceutical industry focused primarily on the research, development, registration and commercialization of biopharmaceutical products made using recombinant DNA technology. He holds 13 patents and has several patent applications pending for biologic products.

Joe earned a B.S. degree in Chemistry from Southeast Missouri State University and a Ph.D. degree in Biochemistry from the University of Tennessee Center for the Health Sciences. After receiving his Ph.D., Joe was awarded a post-doctoral fellowship in Molecular Biology at the prestigious Roche Institute of Molecular Biology, in Nutley, NJ. Following his fellowship, Joe was hired to be a senior scientist to develop the large-scale protein purification processes necessary for the manufacture of Recombinant Protein Therapeutics. Interferon Sciences, Inc. recruited Joe from Hoffman-LaRoche, and he later held senior positions at Scios (acquired by Johnson & Johnson), CellPro, Inc. (cell therapeutics company), and ImClone Systems Incorporated (acquired by Eli Lilly). While at ImClone Systems, he grew the company’s Branchburg, NJ Campus from one building on six acres to seven buildings on nearly 50 acres. After the completion of its second manufacturing plant in 2005, ImClone Systems was one the world’s largest mammalian cell culture manufacturers.

Joe has held critical roles in the manufacturing, process development, registration, and launch of several FDA and internationally approved human therapeutic products, including Roferon® A, Alpheron N®, Fiblast® Spray, CEPRATE® SC Stem Cell Concentration System, Natrecor®, Erbitux® Orencia®, Yervoy®, Nulojix®, Eperzan®/Tanzeum®, Nucala®, and Strimvelis™. He has a thorough understanding of the biologics drug registration process and has had extensive experience in developing the Chemistry, Manufacturing and Controls (CMC) sections for many Investigational New Drug and Biologics License Applications.