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

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]