AABB Webinar: Human Platelet Lysate Use in the Production of Cellular Therapies: Current State of the Art and Challenges to be Resolved
Thursday, August 4, 2016
2:00 – 3:00 PM (ET) 7:00 – 8:00 PM (GMT)
Join participants from the Joint AABB-ISCT Working Group on Human Platelet Lysates to learn about current status and challenges of the production, standardization, pathogen reduction and quality control of HPL. Three experts in the field will present key areas of development that are critical to clinical translation of HPL. There will be three main topics presented:
Topic 1 Focus: Human platelet lysate (HPL) is being used as a substitute for FBS as a media supplement for manufacture of Advanced Therapies Medicinal Products. Here we will review different methods that can be used for producing HPL and discuss important considerations and challenges.
Topic 2 Focus: HPL is a potent media supplement for the manufacture of cell therapies. However, platelet units bear the risk of bacterial and viral contamination. As reported, pathogen reduction (PR) can decrease such contamination risks. This presentation will discuss current PR concepts and their implications on HPL production and quality.
Topic 3 Focus: HPL versus FBS for Human cell preparations: Most clinical trials have been performed with MSC isolated and expanded in fetal bovine serum (FBS). However, regulatory authorities request to avoid FBS once alternative culture substitutes are available. Comparative analyses indicate hPL as suitable alternative to FBS in a variety of applications in advanced somatic cell therapy and tissue engineering. However, minor differences appear to exist. The presentation will discuss data regarding the potential of hPL to replace FBS.
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Director/ Moderator: Shibani Pati, MD, PhD, Scientific Director of Cellular Therapies, Blood Systems Research Institute, Associate Professor, UCSF
Speakers: Participants from the Joint AABB-ISCT Working Group on Human Platelet Lysates:
- Richard Schäfer, MD, Assistant Professor, Assistant Medical Director, Head Department Cell Therapeutics & Cell Processing, Head QC, Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden-Württemberg-Hessen gGmbH, Goethe University Hospital, Frankfurt/Main, Germany
- Jo-Anna Reems, PhD, Scientific Director, Cell Therapy & Regenerative Medicine Facility, Professor (Research), Division of Hematology & Hematologic Malignancies, University of Utah School of Medicine, Salt Lake City, UT
- Leela L. Paris, PhD, Laboratory Director, Cook Regentec, Indianapolis, IN
Intended Audience: Physicians, Scientists, Technologists, Nurses
Teaching Level: Basic to Intermediate
Learn about different protocols for HPL production.
Identify pros and cons of different protocols for HPL production.
Get a few ideas around key HPL manufacturing challenges.
Learn about current PR concepts.
Discuss implications of PR on HPL production.
Discuss possible implications of PR on HPL quality.
Examine the use of FBS to two different platelet lysate (PL) derivatives, PL-serum and PL-plasma.
Explore differences/similarities of Mesencyhmal stromal/stem cells (MSCs) cultured with PL-S and PL-P.
Proliferation responses & doubling times
Compare visual qualities, turbidity levels and proliferation qualities of platelet lysates that are distributed by different vendors.
Richard Schäfer, MD
Dr. Schäfer is heading the Department of Cell Therapeutics at the German Red Cross Blood Donor Service in Frankfurt, Germany. He has worked extensively in the area of pluripotent stem cells including re-programming at the Harvard Stem Cell Institute as well as in the Mesenchymal Stromal/Stem Cell (MSC) and Neural Stem Cell field at the Universities Tübingen, Harvard and Stanford. He has developed animal-serum free culture of MSCs, identified human MSC subpopulations and, as a blood banker, pioneered in development of pathogen reduced convalescent plasma. His goal in basic research is to contribute to our understanding of stem cell differentiation and function in regeneration and immunomodulation. Being dedicated to the translation of stem cell biology to the clinic, his goal in translational research is development and manufacture of stem cell therapeutics.
Jo-Anna Reems, PhD
Dr. Reems earned her PhD in Biochemistry at the University of Colorado Health Sciences Center in Denver, CO. During her post-doctoral training at the Fred Hutchinson Cancer Research Center she began studies to investigate regulatory mechanisms responsible for the growth and development of hematopoietic stem and progenitor cells with an emphasis on the fascinating process of megakaryocytopoiesis. In 1996, she joined Blood Systems in Tempe Arizona as the Director of Research and later moved to the Puget Sound Blood Center in Seattle. She is currently employed at the University of Utah as the Scientific Director of Cell Therapy and Regenerative Medicine. Her extensive experience in developing and optimizing methods to isolate somatic cells (e.g. pancreatic islets, CD34+ cells, T-regs) as well as in expanding and engineering stem/progenitors cells has resulted in the delivery of multiple novel cellular therapeutic products to patients. Dr. Reems also participates on national and international committees to improve and optimize strategies for the advancement of cellular therapies and regenerative medicine.
Leela Paris, PhD
Dr. Paris is the laboratory director at the Indianapolis Facility of Regentec (Cook General Biotechnology). Prior to joining CGBT in July of 2014, she was an Assistant Professor at Indiana University School of Medicine in the department of surgery, transplant division. Her research involved porcine organ xeno-transplantation. More specifically, she worked on thrombocytopenia that occurs following porcine liver xeno-transplantation, as well as xeno-transplant immunology, and genetic modification of cells used for somatic cell nuclear transfer. Before working at IU, Leela received her PhD in Medicinal Chemistry and Molecular Pharmacology from Purdue University. Her dissertation looked at the role of S291 phosphorylation on Spleen Tyrosine Kinase (Syk). She has had multiple collaborations in academia and industry working with combining biology with new analytical methods.