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. 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.

Our CliniPrime™ Fresh Leukopaks follow a standardized production process to rapidly provide starting material for your program. GMPrime™ Fresh Leukopaks allow you to customize production processes for starting materials that meet the specific needs of your program.