LOS ANGELES--(BUSINESS WIRE)--HemaCare Corporation (OTCMKTS: HEMA), a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cellular therapy process development, today announced that it has expanded its portfolio of GMP-compliant cellular material with the launch of GMPrime bone marrow aspirate. GMP-compliant bone marrow aspirate is in high demand globally and a critical starting material in the development of cell and gene therapies.
Due to the extreme versatility of bone marrow-derived cells, invasive collection procedure, and limited access to qualified suppliers, sourcing sufficient GMP-compliant bone marrow is an immense challenge for the research, scientific, and clinical community. As a therapy moves from preclinical to clinical development, high-quality, consistent starting material is essential. Early transition to GMP-compliant starting materials is the easiest way to ensure regulatory compliance upon entering the clinical environment.
GMPrime bone marrow aspirate is collected within HemaCare’s FDA-registered collection center from IRB-consented donors following rigorous and standardized processes to ensure the highest achievable purity, viability, and quality. HemaCare, with over 40 years of donor management experience, possesses one of the industry’s largest reliable pedigreed donor networks.
“Bone marrow-derived cell therapy starting materials are being used to support the development of a wide variety of new cell and gene therapies,” said Dominic Clarke, Ph.D., Global Head of Cell Therapy for HemaCare. “Launching HemaCare’s GMPrime bone marrow aspirate ensures the industry experiences a smoother transition from research to process development through to commercialization. This product adheres to the same stringent quality standards and optimized protocols as our HemaPrime™ (research use only) bone marrow aspirate. It will, however, come with the added full QA review and documentation necessary to meet regulatory requirements needed for commercial development.”
Commitment to supporting the rapidly growing cell and gene therapy industry is of utmost importance to HemaCare. By expanding its GMP portfolio, researchers can now choose GMP-compliant bone marrow aspirate as they transition from preclinical to clinical development, thus ensuring consistent, validated, and fully documented quality.
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 ensures fresh donor material is available to customers and for use within HemaCare’s cell isolation laboratory. Human biological material, including peripheral blood, bone marrow, and cord blood, is isolated into various primary cell types for fresh and frozen distribution. For over 40 years, HemaCare has developed an extensive registry of recallable and reliable 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.