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. Author manuscript; available in PMC: 2018 Jan 1.
Published in final edited form as: Clin Pharmacol Ther. 2016 Nov 21;101(1):31–34. doi: 10.1002/cpt.527

Figure 1. Quality control in sourcing and manufacturing.

Figure 1

Schematics of the quality control practices in traditional (A) and stem cell (B) manufacturing. The amounts of good (green) and defective (red) products in each phase is pre-determined through complete qualification of materials (fill color) and manufacturing (edge color) steps. Unfortunately, patient-specific pools of regenerative cells are sorted based on incomplete characterization, such as the expression of surface markers (outer shell), as key parameters underlying regenerative (yellow core) and non-regenerative (blue core) phenotypes are difficult to characterize. Further how manufacturing and the interaction with the host affect the regenerative cell phenotype is also unclear. As a result, manufacturing of cGMP-grade non-regenerative cell products for regenerative medicine application may occur.