GMP-compliant Leukopaks

GMP-compliant leukopaks are collected in our 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. We can perform collections that meet your specific criteria and/or follow your protocols. Our 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.

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GMPrime™ Leukopak

SKU PB001F-1-GMP
Product Code: PB001F-1-GMP
Description: 1 Bag
Format: Fresh
Source: Peripheral Blood
Status: Healthy
Viability: >95% by flow cytometry

GMPrime™ Leukopak

SKU PB001CLP-GMP-1-KIT
Product Code: PB001CLP-GMP-1-KIT
Description: 1 Bag
Format: Cryopreserved
Source: Peripheral Blood
Status: Healthy
Viability: >95% by flow cytometry
Contains: CryoStor® CS10