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. 2023:1420:81-95.
doi: 10.1007/978-3-031-30040-0_6.

Advanced Technologies for Potency Assay Measurement

Raghavan Chinnadurai  1
Affiliations

Advanced Technologies for Potency Assay Measurement

Raghavan Chinnadurai. Adv Exp Med Biol. 2023.

Abstract

Crucial for their application, cell products need to be well-characterized in the cell manufacturing facilities and conform to regulatory approval criteria before infusion into the patients. Mesenchymal Stromal Cells (MSCs) are the leading cell therapy candidate in clinical trials worldwide. Early phase clinical trials have demonstrated that MSCs display an excellent safety profile and are well tolerated. However, MSCs have also exhibited contradictory efficacy in later-phase clinical trials with reasons for this discrepancy including poorly understood mechanism of MSC therapeutic action. With likelihood that a number of attributes are involved in MSC derived clinical benefit, an assay that measures a single quality of may not adequately reflect potency, thus a combination of bioassays and analytical methods, collectively called "assay matrix" are favoured for defining the potency of MSC more adequately. This chapter highlights advanced technologies and targets that can achieve quantitative measurement for a range of MSC attributes, including immunological, genomic, secretome, phosphorylation, morphological, biomaterial, angiogenic and metabolic assays.

Keywords: Angiogenic assays; Assay matrix; Biomaterial based assays; Genomic assays; Immunological assays; MSC release criteria; Metabolic assays; Morphological profiling assays; Phosphorylation assays; Secretome assays.

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