GMPrime™ Leukopak



Peripheral Blood



Viability:>95% by flow cytometry
Viability:>95% by flow cytometry
Contains:CryoStor® CS10

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1 Bag PB001F-1-GMP
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Product Overview:

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.

Storage Conditions:

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.

Leukopak Flow Data

Representative flow data: Flow data on Certificate of Analysis for fresh leukopaks available upon request.

CD45 versus PI flow data
CD45 and Propidium Iodide (PI) are used to assess purity and viability of leukopaks. CD45 is expressed on all leukocytes and is used to indicate purity of the white blood cell component. PI cannot pass through the membrane of live cells to stain DNA, thus, it serves as an indicator of viability. CD45 values in our leukopaks is typically observed to be between 30-60%.

CD45 versus CD3 flow data
CD3 is a multimeric surface molecule expressed commonly by T cell populations. Assessing CD3 versus CD45 helps enumerate what percentage of white blood cells within the sample are T cells. Representative data shown here indicates a relative T cell population of 48.31%. (May not be indicative of received samples.)

CD8 versus CD4 flow data
CD4 and CD8 are co-receptors that can be used to distinguish the two major classes of T cells – helper and cytotoxic, respectively. The ratio of CD4 and CD8 cells can be used as a marker of immune activation and immune senescence. Representative data indicates a typical CD4/CD8 ratio that is around 2 but may vary depending on the health of donor. (May not be indicative of received samples.)

CD45 versus CD14 flow data
CD14 is a marker expressed on multiple cell types, including monocytes, macrophages, and neutrophils. Assessing CD14 versus CD45 within the mononuclear cell component of peripheral blood will enumerate what percentage of the sample are monocytes. Representative data illustrates a relative monocyte population of 24.06%. (May not be indicative of received samples.)

CD45 versus CD19 flow data
CD19 is one of the proteins found in the B-cell co-receptor complex. It can be used as a marker for the identification and quantification of B cells within the sample. Assessing CD19 vs. CD45 will enumerate what percentage of the white blood cells within the sample are B cells. Representative data illustrates a relative B cell population of 12.93%. (May not be indicative of received samples.)

CD45 versus CD56 flow data
CD56 or neural cell adhesion molecule (NCAM) is a homophilic binding glycoprotein expressed on the surface of natural killer (NK) cells. It can be used to identify the relative frequency of NK cells within the white blood cell (WBC) population. Assessing CD56 vs. CD45 will enumerate what percentage of the WBCs within the sample are NK cells. Representative data illustrates a relative NK cell population of 12.34%. (May not be indicative of received samples.)

Certificate of Analysis is customized to meet the specific requirements of the customer.