HemaCare Corporation, a Charles River Laboratories company, has expanded its portfolio of GMP-compliant cellular material with the launch of the GMPrime cryopreserved leukopak. The GMP-compliant cryopreserved leukopak includes a quality assurance (QA)-reviewed Certificate of Analysis, thus adding QA review to HemaCare’s popular research use (HemaPrime) cryopreserved leukopak. HemaCare’s GMPrime leukopaks are cryopreserved following a proprietary cryopreservation process and meet the requirements of the most rigorous quality standards required by regulatory agencies. GMPrime cryopreserved leukopaks extend shelf life and stability and provide researchers and cell therapy developers with the consistency needed in a cellular starting material used for the development and commercialization of next-generation cell and gene therapies.
Maintaining optimal function of key raw materials used to develop cell-based therapies is of prime importance. Factors such as site-to-site or international shipping of fresh leukopaks will impact cell viability and function. Cryopreserving a leukopak directly following collection significantly improves complex logistical hurdles by protecting product quality, mitigating risks during shipping, and allowing scheduling flexibility when planning and coordinating downstream processing activities, ultimately giving researchers and clinicians the freedom to plan, prepare, and perform studies on their timelines while preserving viability and functionality.
“Cryopreservation of leukopaks plays a critical role in the research and development continuum as this process simplifies complex logistics typically involved in working with raw human starting materials such as shipping, planning, and resource allocation while also providing the consistency, stability, and quality the industry desires,” said Dominic Clarke, Ph.D., Global Head of Cell Therapy for HemaCare. “The launch of HemaCare’s GMPrime cryopreserved leukopak ensures the industry experiences a flexible and seamless transition as they move their therapy from research to commercialization.”
GMPrime cryopreserved leukopaks are collected within HemaCare’s FDA-registered collection center from IRB-consented donors and immediately cryopreserved onsite within Class A and B (ISO 5 and 6) cleanroom environments. HemaCare’s HemaPrime and GMPrime cryopreserved leukopaks adhere to the same stringent quality standards and are collected and processed following standardized protocols to ensure the highest achievable purity, viability, and quality thus ensuring researchers can seamlessly transition from development to clinical trials to commercialization with confidence.