Downstream Processing Challenges in Cell Therapy Manufacturing

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  • เผยแพร่เมื่อ 22 เม.ย. 2019
  • Presented By:
    Jim Beltzer, MS, PhD - Sr. Manager, Global Strategic Medical Affairs, Cell Therapy Technologies - Terumo BCT
    Speaker 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.
    Co-Presented By:
    Geoffrey Uhl, MBA, BS - Sr. Engineering Manager, Cell Processing - Terumo BCT
    Speaker 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.
    Webinar:
    Downstream Processing Challenges in Cell Therapy Manufacturing
    Webinar Abstract:
    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.
    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
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