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APR 20, 2020 9:00 AM PDT
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Hematopoietic Cell Therapy Products: Determining Potency and Stability

Sponsored by: STEMCELL Technologies
C.E. Credits: P.A.C.E. CE ｜ Florida CE
+50pts
Speaker
  • Jackie Damen, PhD
    Hematopoietic Cell Therapy Products: Determining Potency and Stability
    Biography
      Dr. Jackie Damen is the Senior Scientific Advisor of the Hematopoiesis department at STEMCELL Technologies. In a career spanning over 20 years, Dr. Damen has acquired extensive experience in the field of hematopoiesis, where her key strengths lie in stem cell biology, protein biochemistry, and signalling, especially in the area of erythropoietin. In her role as Senior Scientific Advisor, Hematopoiesis, as well as her past experience as Director of Contract Assay Services at STEMCELL Technologies, Dr. Damen has conducted hundreds of customized studies involving the CFU assay to provide numerous pharmaceutical and biotechnology clients with solutions to their drug development questions. Dr. Damen actively participates in several educational initiatives, regularly providing online talks and presentations of topical interest at high profile conferences such as the Society of Toxicology Annual Meeting. At STEMCELL Technologies, Dr. Damen has been involved in customer training of hematopoietic stem cell biology and colony identification since 2002.
    Abstract
    DATE:  April 20, 2020
    TIME:   9:00am PT, 12:00pm ET
     
    There are unique challenges when it comes to cell therapy products, including ensuring the reproducibility and consistency of product lots. These specific concerns arise from the inherent variability of the starting material, which often comes from multiple patients or donors. Before using these cells as therapy, the quality–including both purity and potency–of the final product must be established. This in turn requires reliable cell assays.
     
    The best type of assay to measure the functionality of hematopoietic stem and progenitor cells (HSPCs) is an in vivo mouse model engraftment study; however, these types of assays are time-consuming, expensive, and difficult to evaluate. Therefore, the in vitro colony-forming unit (CFU) assay, which has been shown to correlate well with in vivo engraftment models, is recommended to evaluate the quality of HSPCs used in cell therapy. Several cord blood bank accrediting bodies (including AABB and FACT) now require pre-freeze CFU data from cord blood collection, as evidence of sample stability and to ensure there is minimal loss of HSPCs during processing and cryopreservation.
     
    In this webinar, Dr. Jackie Damen of STEMCELL Technologies will explore the need for standardized potency assays for hematopoietic cell products and review recent publications that evaluate the effects of cryopreservation protocols on the potency of cell therapy products. Dr. Damen will define the CFU assay and explore its utility as part of the cell therapy workflow. She will also define simple steps that can help ensure standardization of the CFU assay, including the use of automated imaging and analysis of cultures.
     
    Learning Objectives:
    • Define the CFU assay and its characteristics as a biological tool in identifying hematopoietic stem and progenitor cells
    • Identify publications using the CFU assay to verify the potency and stability of Hematopoietic Cellular Therapy Products
    • Understand the utility of the CFU assay in the processing and manufacturing of Hematopoietic Cellular Therapy Products
     
     
    Webinars will be available for unlimited on-demand viewing after live event.
     
    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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