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Simplify complex study logistics with GMP-compliant cryopreserved leukopak for the development and commercialization of 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
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.
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.
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