The product your lab chooses to fulfill their research needs largely depends on the stage of development. Are you conducting early drug discovery research involving several different candidates? Perhaps your company is involved in translational research, considering a lead candidate for clinical studies? What is your research budget? Choosing the right starting material for a specific project is a critical decision, but one that can sometimes be daunting.
HemaCare has now published an educational infographic to inform and simplify that decision. This infographic succinctly describes the similarities and differences between their HemaPrimeTM (research use) and GMPrimeTM (GMP-compliant) cryopreserved leukopak products. Regulatory compliance procedures, labeling, biosafety testing, and more are clearly spelled out to guide your decision.
Cryopreservation provides a convenient means of ensuring that research and manufacturing needs are met in a timely manner. Adopting the use of cryopreserved leukopaks early in drug development can help streamline the transition from research to commercialization. Cryopreservation is often a logistical necessity for protecting the integrity of cell therapies during shipping, and for providing scheduling flexibility. While some researchers may still harbor reservations regarding fresh-vs-cryopreserved leukopak quality, the fact is that when cryopreservation is done right, the efficacy and viability of cryopreserved leukopaks is equivalent to, and under certain circumstances, superior to, freshly isolated products.
Reliable access to high-quality leukapheresis starting material is always a primary concern for those involved in the development of cell therapies and other advanced medicinal products. This has become truer than ever today, as the covid-19 pandemic impacts donor availability and pharmaceutical supply chains. Cryopreserved leukapheresis materials are more readily available than fresh material during the current health crises, and likely to remain so for some time as research slowly ramps back up to pre-pandemic levels. Aside from sourcing concerns, many researchers are realizing that cryopreserved leukopaks can also provide greater consistency, since all such products are collected and processed the same way, and can, upon request, be supplied as identical fractions of the same donor batch.
At HemaCare, we are committed to supplying only the highest quality of leukapheresis materials, by implementing strict validation and qualification guidelines. Don’t let uncertainty stand in the way of expediting your research! Visit our website today and choose the product that works best for you.