A Quality Assessment Round (QAR) is a process by which a community of scientists develops greater assurance that the testing carried out is consistent with that of others in the community (i.e. that testing is consistent and reliable across sites).
These QARs specifically focus on quality tests for iPSC lines where Pharmacopeial guidance is currently lacking, and seek to provide greater confidence in the reliability of iPSC quality testing.
The QARs follow on from the publication of:
‘Quality control guidelines for clinical-grade human induced pluripotent stem cell lines’
in September 2018 and the first iPSC QAR in 2019. They are part of a larger ongoing QC process to enable use of clinical-grade iPSC lines as a starting material for the generation of cellular therapeutics.
The ultimate goal of this larger QC process is demonstration of comparability of lines derived from different individuals and in different facilities associated with the GAiT global haplobank network.
