Potency evaluation of tissue engineered and regenerative medicine products.
Methodologies for the rigorous and quantitative evaluation of biological activity or potency are an essential aspect of the developmental pathway for all biologic product candidates. Such assays typically leverage key mechanistic pathways demonstrated to mediate observed therapeutic outcomes. Tissue engineered/regenerative medicine (TE/RM) therapeutics include cell based therapies as well as engineered tissues and neo-organs for which clarity regarding the mechanism or mechanisms of action may not be forthcoming. Here, we discuss how strategies for the development of potency assays for TE/RM product candidates may harness potential mechanisms of action or other therapeutically relevant bioactivity along with cell number and viability. As the pipeline for TE/RM product candidates expands through 2014 and beyond, the establishment of a defined framework for potency assays will facilitate successful translational outcomes.
Process Research and Translation, Tengion, Inc., 3929 Westpoint Blvd., Suite G, Winston-Salem, NC 27103, USA.
Kelly
K
Guthrie
Andrew
A
Bruce
Namrata
N
Sangha
Elias
E
Rivera
Joydeep
J
Basu
D000818:Animals; D001187:Artificial Organs; D001672:Biocompatible Materials; D064987:Cell- and Tissue-Based Therapy; D006801:Humans; D044968:Regenerative Medicine / Q000379:methods* / Q000639:trends*; D023822:Tissue Engineering / Q000379:methods* / Q000592:standards*
D001672:Biocompatible Materials
cell therapy; potency; regenerative medicine; tissue engineering