A Leukopak is a highly-enriched leukapheresis-derived product obtained from an IRB-approved collection facility. Leukopaks contain higher concentrations of mononuclear cells, B cells, T cells, stem/progenitor cells, dendritic cells, and other cell types as compared to standard venipuncture collection methods or buffy coat products.
Leukapheresis is performed using the Spectra Optia® Apheresis System with healthy, consented donors following IRB-approved protocols. MNC rich cells are continuously collected from 2-2.5 donor blood volumes into a sterile bag using ACD-A as an anticoagulant. Approximately 120mL of autologous plasma is automatically collected directly into the cell pool following leukapheresis. Following collection, a total nucleated cell count is determined using AO/PI. A defined quantity of 5 billion apheresed cells (including a target overfill) is transferred into sterile containers. The total volume and concentration of the supplied cells will vary. Based on this count, the product is filled to deliver not less than 5 billion cells at release.
Leukopaks typically contain up to 50% T cells, 20% monocytes, 10% B cells, and 10% NK cells, 3% granulocytes, and 3 % hematocrit. Actual percentages will vary from donor to donor.
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