HemaCare 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.”