Live Program Date: August 4, 2016 –
Master Program Number: 1613 (see program format numbers below under Registration)
Topic: Cellular Therapies
Intended Audience: Physicians, Scientists, Technologists, Nurses
Teaching Level: Basic to Intermediate
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
After participating in this educational activity, participants should be able to:
- 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
- Gene expression
- Compare visual qualities, turbidity levels and proliferation qualities of platelet lysates that are distributed by different vendors.
Participants from the Joint AABB-ISCT Working Group on Human Platelet Lysates discussed the current status and challenges of the production, standardization, pathogen reduction and quality control of HPL. Three experts in the field presented key areas of development that are critical to clinical translation of HPL. The 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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