Fig. 1

Intra- (n = 45) and inter-batch (n = 49) differences in CD34⁺cell recovery and potency between runs. Post-processing viable CD34⁺ cell dose was assessed by flow cytometry (modified ISHAGE now ISCT) and reported as CD34⁺ cell recovery compared to pre-cryopreservation dose. (A) Intra-batch and inter-batch CD34⁺ cell recovery data is plotted using a Bland-Altman plot. The y-axis represents the percent difference between 2 runs pertaining to the same patient vs. the mean CD34⁺ cell recovery between the 2 runs on the x-axis. The bias (agreement between both runs) is plotted as a dotted line, while the shaded area marks the 95% limits of agreement. (B) Intra-batch (left) and inter-batch (right) viable CD34⁺ cell doses are plotted by patient for each of the runs. (C) For 9 allogeneic grafts, a CFU-GM assay was performed via a 14-day culture followed by automated cell counting to report clonogenicity. Data are plotted per patient for each of the two runs pertaining to that patient