The two-pronged goal of the AABB-ISCT Stability Project Team (SPT) is to understand current stability program practices among HSPC manufacturing facilities and to provide a roadmap toward standardization or best practices based on scientific evidence, using the general framework for stability testing found in 21 CFR 211.166. There are several challenges to establishing a stability program for cryopreserved HSPC, including the lack of 1) a consensus test or surrogate marker to predict HSPC hematopoietic engraftment efficacy post-transplant 2) standardization for flow cytometry-based post-thaw viable target cell enumerations that can be paired with the International Society of Hematotherapy and Graft Engineering (ISHAGE) protocol and 3) standardization regarding optimal sampling (number and frequency) of products to assess program effectiveness. Currently there is no single assay, which is accepted by consensus in the cell therapy field to accurately predict the engraftment potential of cryopreserved HSPC products. KeywordsĪbbreviations: AABB ( association for the advancement of blood & biotherapies), ALDH ( aldehyde dehydrogenase), CAP ( college of american pathologists), CFU ( colony forming unit), DMSO ( dimethylsulfoxide), FACT ( foundation for the accreditation of cellular therapy), FDA ( food and drug administration), HAS ( human serum albumin), HCT/Ps ( human cells, tissues, and cellular and tissue-based products), HPC ( hematopoietic progenitor cells), HSPC ( hematopoietic stem/progenitor cells), ICH ( the international council for harmonization), ISHAGE ( international society of hematotherapy and graft engineering), LN2 ( liquid nitrogen), NA ( north america), PI ( propidium iodide), QA ( quality assessment), QC ( quality control), SPT ( stability project team), TB ( trypan blue), 7-AAD ( 7-amino-actinomycin D) The survey results emphasize the need for the community to optimize best practices and consider initiating collaborative projects to improve the standardization of cryopreserved HSPC stability programs for cell therapy products. The SPT recommendations for best practices are not intended to replace existing standards.
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