APR 11, 2019 10:00 AM PDT

Downstream Processing Challenges in Cell Therapy Manufacturing

Sponsored by: TERUMO BCT
C.E. Credits: P.A.C.E. CE Florida CE
Speakers
  • Sr. Manager, Global Strategic Medical Affairs, Cell Therapy Technologies - Terumo BCT
    Biography
      Jim recently transitioned to the Global Strategic Medical Affairs team to better leverage both his technical background and the commercial exposure he has gained during his more than seven years at Terumo BCT. Prior to joining the cell processing team at Terumo BCT, Dr. Beltzer was the lead scientist for the research and development of Synthemax™, a synthetic growth surface for the culture of human embryonic stem cells, at Corning Life Sciences. He was a co-founder of RETT Corporation and was a key player in the industrialization of several technology platforms, including phage display and yeast two-hybrid. He has more than 25 years of industrial research and development experience in a broad range of disciplines.
    • Sr. Engineering Manager, Cell Processing - Terumo BCT
      Biography
        Geoff currently leads the product development efforts for the Cell Therapy Technologies portfolio at Terumo BCT. He previously led teams engaged in development of single-use disposable medical devices across several Terumo BCT product lines. Prior to joining Terumo BCT, Geoff developed complex electromechanical systems in the fields of medical simulation and laboratory instrumentation. Throughout his 18-year career, Geoff has earned three U.S. patents for his contributions to product development efforts.

      Abstract
      DATE: April 11, 2019
      TIME: 10:00 AM PDT
       
      With the recent FDA approval of the CAR T-cell therapies Kymriah® from Novartis and Yescarta® from Kite Pharma, there has been a renewed interest in bioprocessing and the manufacturing facilities required to meet the commercial demands for these novel cell therapy products. Much of the industry focus has been on the upstream process, with particular emphasis on large-scale cell expansion. In fact, optimization of bioreactor yields often results in downstream process bottlenecks. The challenges of cell therapy process development that arise after the cell expansion stage can include harvesting, washing, cell purification, cell concentration, formulation, fill and finish, and preservation, depending upon the therapy.
       
      A successful commercial production process must be scalable, robust and reproducible and must result in a therapy that is affordable. Compounding the difficulty, many current cell separation technologies are not compatible with large-scale processes. Since the product is the process, manufacturing processes must maintain the functionality and the critical quality attributes of the cellular material throughout.
      Who may be interested:
      • Clinicians, researchers, lab technologists and cell therapy industry professionals
      • Cell and gene therapy manufacturing professionals
      • Contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs)
      Learning objectives:
      • Gain a greater understanding of the downstream part of the cell processing and its challenges
      • Understand the strengths and weaknesses of current approaches
      • Discover a new option in the area of final formulation, fill and finish—the Finia® Fill and Finish System from Terumo BCT
       
      LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.
       

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