A leukopak is an enriched leukapheresis product collected from normal peripheral blood. It is composed of a variety of blood cells including monocytes, lymphocytes, platelets, plasma, and red cells. A leukopak contains a higher concentration of cells as compared to standard venipuncture collection methods or buffy coat products.
GMP-compliant leukopaks are collected in HemaCare’s FDA-registered collection centers from IRB consented healthy human donors by leukapheresis using the Spectra Optia® Apheresis System CMNC collection protocol in ACD-A anticoagulant. HemaCare can perform collections that meet your specific criteria and/or follow your protocols.
HemaCare’s GMP-compliant qualification requires implementation of SOPs and formal quality systems that result in reduced variability and risk. Specifically, our GMP-compliant products require comprehensive employee training, competency assessments, and documentation of training as well as stringent material traceability and equipment logs. Additional quality performance testing and monitoring of quality indicators ensure industry-leading quality and stability.
Use fresh leukopaks immediately upon receipt.
For cryopreserved leukopaks, either prepare cells for long-term storage in Liquid Nitrogen vapor phase or thaw for use. Storage in liquid phase nitrogen is NOT recommended. Short-term storage of cells (less than 2 weeks) at -80°C is acceptable but should be minimized to ensure maximum stability. Once thawed, samples must be used immediately.
Testing: Donors are tested for HBV, HCV, HIV, HTLV, WNV, Trypanasoma cruzi, and Syphilis.