Figure 3: Global gene expression analysis of a lot of BMSCs that failed release criteria and two lots manufactured from the same starting material.

Five lots of BMSCs manufactured by Center #6 (magenta) were analyzed by global gene expression analysis. Four of the lots met lot release criteria and are also shown in Fig. 1 and one BMSC lot failed lot release criteria, 6-E (arrow), due to slow growth of the primary culture. The results of PCA are shown in Panel A and unsupervised hierarchical clustering analysis in panel B. A marrow aspirate from one healthy subject was collected and split into multiple aliquots and cryopreserved and on two separate occasions, an aliquot was thawed and used by Center #5 (burgundy) to manufacture BMSCs. These two lots and two others from Center #5 were subjected to global gene expression analysis and PCA is shown in Panel C and unsupervised hierarchical clustering analysis in Panel D. Results of analysis of lots A, B and D from Center 5 (5-A, 5-B and 5-D) are also shown in Fig. 1. The results of analysis of fibroblasts (blue) and CD34⁺ cells (green) from healthy subjects are shown as controls.