Whether for nonclinical, or clinical applications, controls are the key for reliability of assay performance.
The US FDA 21 CFR Part 58.105-107 and 42 CFR Part 493.1256 describe control article characterization and procedures for nonclinical and clinical laboratory testing and/or studies. These critical materials provide the necessary data to ensure the reliability and validity of the testing articles.
CTL’s ePBMC™ library of cells is an ideal, easy-to-use tool in assay standardization. Available in single donation aliquots, the ePBMC™ have been pre-characterized to allow clients to select the most relevant ePBMC™ cell material for their specific assays.
CTL’s ImmunoSpot® Kits provide a wide range of in vitro immune monitoring products to enhance researchers, biotechnology and pharmaceutical organizations safety and efficacy evaluations. ImmunoSpot® kits undergo rigorous Quality Control efforts in accordance to applicable ISO 13485:2016 standards