Journal: Cytotherapy

Article Title: Cryopreserved hematopoietic stem/progenitor cells stability program-development, current status and recommendations: A brief report from the AABB-ISCT joint working group cellular therapy product stability project team.

doi: 10.1016/j.jcyt.2022.03.001

Figure Lengend Snippet: Figure 1. Types of stability testing. (A) the majority of programs perform multiple tests to evaluate stability. Of 58 programs providing answers for type of stability testing questions, all perform viability testing (58/58), followed by CD34 enumeration 86% (50/58), Total nucleated cell (TNC) enumeration 83% (48/58), and potency 74% (43/58). The majority of pro- grams, 93% (52/58), perform multiple stability tests. Stability testing only for viability is reported by 7% (4/58) programs. Regarding type of potency assay, 58 participants provided answers of these 15/58 (26%) responders report not testing for functional potency. B) Type of functional potency assay: 43 participants performed stability testing. There were total 51 potency tests from 43 responses having multiples types of potency tests being done for a single product. 24/43 (56%) perform colony forming unit (CFU) assay, while the remain- ing 23/43 (53%) responders use 7-AAD viable CD34+ cells as a surrogate for potency assay. Two centers reported using aldehyde dehydrogenase (ALDH) enzymatic function-based flow cytometry assay, and 2 centers reported using hematopoietic engraftment to determine potency of cryopreserved HSPC. (C) Types of viability testing performed: TNC viability by trypan blue 45% (26/58), TNC viability by 7-amino Actinomycin D (7AAD) 52% (30/58), CD34 viability by 7AAD 74% (43/58), and automated fluorescence 12% (7/58). The majority of programs, 64% (37/58), perform combination CD34 and TNC viability testing. Notably, 4/58 (7%) programs that reported viability testing as the only stability test perform CD34 7AAD [Color figure can be viewed at (Color version of figure is available online)].

Article Snippet: While retention of hematopoietic engraftment potential is the primary goal for cryopreserved HSPC stability, engraftment results should not be used as the Keywords: CD34+ cell Cryopreservation Functional assay Hematopoietic stem/progenitor cells Potency Recovery Stability of blood & biotherapies; ALDH, aldehyde dehydrogenase; CAP, college of american pathologists; CFU, colony forming unit; ditation of cellular therapy; FDA, food and drug administration; HAS, human serum albumin; HCT/Ps, human cells, tissues, etic progenitor cells; HSPC, hematopoietic stem/progenitor cells; ICH, the international council for harmonization; ISHAGE, ring; LN2, liquid nitrogen; NA, north america; PI, propidium iodide; QA, quality assessment; QC, quality control; SPT, stabilmycin D n cryopreserved HSPC product stability are based on a number of factors, including the survey results, current practices, litvant stability testing regulations and accreditation standards.

Techniques: Potency Assay, Functional Assay, Colony-forming Unit Assay, Cytometry