Quality controls of cryopreserved hematopoietic stem cells

Abstract

HPC processing has been performed routinely for many years for the preparation and cryopreservation of HPC used for autologous and allogeneic transplantation. JACIE Standards (section D) regulate HPC processing and request that processing is performed within the framework of a quality management system (QMS). Implementing QMS in HPC-processing laboratories is feasible, and many processing laboratories are already accredited according to various standards.

Before hematopoietic stem cell transplantation, it is recommended that accurate quality controls be performed to assess the median number of viable CD45+/7-aminoactinomycin-d (7-AAD) and CD45+/CD34+/7-AAD cells, the presence of microbiologic contamination, and the proliferative potential of hematopoietic progenitor cells. The guidelines for the determination of the QCs have been established by FACT/JACIE standards.

To be optimal, process and quality controls have to be performed in a real-time manner in order to ensure safe product release and an immediate recognition of deviations. Furthermore, the immediate initiation of corrective measures is crucial for risk prevention.