The final quality control of cryopreserved progenitor cells is a successful and persistent three lineage engraftment after transplantation. Of course, the stem cell providing institution is obliged to have a program for controlling and monitoring the manufacturing of cellular therapy products before the patients’ conditioning therapy is started. The FACT-JACIE Standards [1] and the Netcord ⁄ FACT Stan- dards prescribe that the director of the institute shall define tests and procedures for measuring and assaying cellular therapy products to ensure their safety, viability and integ- rity and shall also ensure that products meet predetermined release specifications. This requires specifications of assays and the definition of thresholds to allow release.

doi.org/10.1111/j.1423-0410.2011.01471.x, hdl.handle.net/1765/30853
Vox Sanguinis
Erasmus MC: University Medical Center Rotterdam

Rosskopf, K., Ragg, S. J., Worel, N., Grommé, M., Preijers, F., Braakman, E., … Panzer, S. (2011). Quality controls of cryopreserved haematopoietic progenitor cells (peripheral blood, cord blood, bone marrow). Vox Sanguinis (Vol. 101, pp. 255–275). doi:10.1111/j.1423-0410.2011.01471.x