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Quality controls of cryopreserved hematopoietic stem cells
Affiliations- Immunohematology Section, Tor Vergata University and CryoLab – Stem Cells Manipulation and Cryopreservation Laboratory, Rome, Italy
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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.
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.
Keywords
HSCT; FACT; JACIE; HPC; EQA; PT; LI; SCE; CB; BM; CD; QCs; 7-AAD; HPC; QMS; ISHAGE; PBPCPs; Hematopoietic stem cells transplantation; Quality controls; CD34+
About this articleTitle
Quality controls of cryopreserved hematopoietic stem cells
Journal
Issue
Pages
347-352
Published online
2015-11-01
Page views
109
Article views/downloads
142
DOI
10.1016/j.achaem.2015.10.002
Bibliographic record
Acta Haematol Pol 2015;46(5):347-352.
Keywords
HSCT
FACT
JACIE
HPC
EQA
PT
LI
SCE
CB
BM
CD
QCs
7-AAD
HPC
QMS
ISHAGE
PBPCPs
Hematopoietic stem cells transplantation
Quality controls
CD34+
Authors
Nicola Daniele
Francesco Zinno