Leukopak

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Each unit contains approximately 10 X 10(9) TNCs.

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End of collection targets of Total Nucleated Cells (TNCs) is 10 billion and is produced from donors meeting all FDA donor selection criteria. Each donor has been tested on the day of collection for all infectious diseases described in 21 CFR 641.Products are labeled using worldwide accepted ISBT labeling format and can be provided for research use only or can be provided meeting all 21 CFR 1271 GMP requirements. Custom doses can also be requested. Concurrent plasma can also be collected and added to the unit or provided separately.

Peripheral Blood Mononuclear Cell (PBMC) apheresis products, often called “Leukopaks” are collected from healthy, non-mobilized donors using automated apheresis. ACD anticoagulant is used at a ratio of 1:13. These products are enriched sources of monocytes and lymphocytes. They also contain platelets, plasma, and red cells. Product is collected to target number of cells, therefore the final volume and cell count will vary.

The leukapheresis procedure used to collect the leukopak is a dual arm apheresis collection procedure that is highly affected by the pre-donation white blood cell count of the donor and the donor’s total blood volume. These factors, along with the total nucleated cells desired in the leukopak, must be used to determine how long the donor should remain on the device.

While the number of cells in the leukopack are determined by donor characteristics and procedure time, the ratio of cells remains relatively constant. Most leukopaks contain up to 50% T cells, 20% monocytes, 10% B cells, and 10% NK cells, 3% granulocytes, with a 3% hematocrit.

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