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Table 2 Overview of testing of regenerative medicine products to validate sterility, stability and potency

From: Transforming healthcare through regenerative medicine

Pillar Obstacles Method Reference
Sterility Sterility testing Direct inoculation test in aerobic and anaerobic media [32]
Stability Chromosomal stability Karyotyping [33]
Cell metabolism Mitochondrial bioenergetics [34]
Safety Animal testing to investigate interactions between native tissue and product [35]
Potency Cell identity Flow cytometry and immunohistochemical analysis [36]
Reproducibility Purity and viability of cell population [37]
  Cell tracking Fluorescent/superparamagnetic iron oxide cell labeling prior to animal implantation [35]