Validation of an apoptosis assay for extracorporeal photopheresis.
Viola HaehnelFrauke DormannKatharina KronenbergJames A HutchinsonRalph BurkhardtNorbert AhrensPublished in: Transfusion medicine (Oxford, England) (2021)
The results of this validation study show that the assay is GMP-compliant and that its reliability, accuracy and precision are acceptable. While pre-analytical stability of the cells was compatible with on-site procedures, our analytical stability data indicate that this assay is not suited for batch mode analysis of ECP products.