HemaCare Provides Starting Material for Three FDA Approved Cellular Therapies
HemaCare Corporation (OTCMKTS: HEMA), a global leader in the customization of human-derived biological products and services for biomedical research and cell therapy, today announces their involvement as a provider of leukapheresis process development material for 100% of the current FDA-approved immunocellular therapies, Kymriah® (Novartis; Switzerland), Yescarta® (Kite, a Gilead Company; CA, USA), and Provenge® (Dendreon; WA, USA).
During the development process, HemaCare worked collaboratively with each company to source healthy donors per project requirements. All leukapheresis material was collected and shipped following stringent standards as developed by the AABB and accepted by the FDA. In some cases, HemaCare performed further processing by splitting collections for comparability runs, freezing material, or adding isolated cells to mimic patient collection material.
Industry cell therapy thought-leaders rely heavily on HemaCare’s extensive and recallable donor database, one of the largest in the industry. “While at Novartis, Biogen, and now Mustang, HemaCare has provided high-quality leukapheresis starting material for process development work. They are highly collaborative, reliable, and a valued partner in the industry,” said Knut Niss, Ph.D., Chief Technology Officer, Mustang Bio, Inc.
Contributing to the overall growth and creation of this new wave of patient therapies has been a long-standing goal for HemaCare. As the company relocates to a new state-of-the-art facility at the end of this year, they will be expanding their onsite GMP capabilities beyond collection to include four clean rooms enabling GMP cell processing, isolation, cryopreservation, and biobanking services to further support the development efforts of novel cellular therapies.
“As an esteemed cell therapy partner, HemaCare is proud to collaborate with companies on the frontier of regenerative medicine, and our upcoming GMP facility and service expansion highlight our continued commitment to aid in the development of next-generation personalized therapies. Delivering high-quality starting material for cell therapies is a priority, as it directly relates to the quality and efficacy of the final cell-based product,” said Lou Juliano, Senior Vice President, Global Sales and Business Development at HemaCare.
For more information about HemaCare, please contact Lou Juliano at firstname.lastname@example.org.
HemaCare is a global leader in the customization of human-derived biological products and services for biomedical research, drug discovery and cellular therapy process development. The company’s network of FDA-registered, GMP/GTP-compliant collection centers ensure fresh donor material is available to customers and for use within HemaCare’s isolation laboratory. Human biological material including peripheral blood, bone marrow, and cord blood is isolated into various primary cells types for fresh and frozen distribution. For 40 years, HemaCare has developed an extensive registry of repeat donors and provides human-derived primary blood cells and tissues for biomedical and drug discovery research and cell therapy clinical trials, and supports commercialization with apheresis collections, directly enabling customers to advance both autologous and allogeneic cellular therapies.
For more information, please visit www.hemacare.com.
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