GMPrime™ Leukopak

$0.00

Source:

Peripheral Blood

Status:

Healthy

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

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Full Collection PB001CLP-GMP-1-KIT
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1 Bag PB001F-1-GMP
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Description

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. Cryopreserved leukopaks are cryopreserved on site immediately following collection. 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.

Click here to learn more about HemaCare’s fresh and cryopreserved leukopak.

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, Trypanosoma cruzi, and Syphilis.

Fresh Leukopak

WBC yield vs Total Number of Donors; Data on HemaCare Fresh LeukopakWBC subpopulation from a HemaCare Fresh Leukopak
Analysis of white blood cell yield and frequency in 2,490 apheresis donors with mean yield being 12.7 x 109 cells/donor and 5th (light blue line) and 95th (purple line) percentiles of 6.4 and 22.9 x 109 (cells/donor).Mean percentages of individual WBC types as measured by flow cytometry.

Cryopreserved Leukopak

Viability Data From A HemaCare GMP Cryopreserved LeukopakWBC Count Data From A HemaCare GMP Cryopreserved LeukopakRecovery Data From A HemaCare GMP Cryopreserved Leukopak
Average total WBC count in fresh leukopaks collected from four donors is 2,175 x106 cells/unit as compared to 1,795 x106 cells/unit in the same leukopaks post thaw.Average percent viability in the cryopreserved leukopaks collected from 4 donors is 97.3% post thaw.Average recovery post thaw is 83%.

Cryopreserved Leukopak Material Handling Sheet

Product Note: GMPrime Cryopreserved Leukopak

Certificate of Analysis

GMPrime Cryopreserved Leukopak

Protocols

How to Thaw Cells in a Cryopreserved Leukopak