Access this 45 minute webinar to learn how to characterise human mesenchymal stem cells in terms of identity, purity and biological activity. The analytical performance of the methods developed have been discussed along with the presentation of experimental results obtained during method development, optimisation and/or validation.
Human mesenchymal stem cells are widely used in the field of cell therapy, a technology used for the replacement and regeneration of dysfunctional cells by healthy functional cells.
The characterisation of human MSCs used for manufacturing cell therapy products requires the development and validation of analytical methods which meet regulatory requirements. Cell therapy products emerge from a long process of cell culture, differentiation and purification where appropriate cell identity, purity and biological activity (potency) monitoring is mandatory. According to minimal criteria proposed by the International Society for Cellular Therapy (ISCT), MSCs must have the ability to adhere to cell culture plastic surfaces, express some phenotypic markers and differentiate into adipogenic, osteogenic and chondrogenic lineages.
Identity and purity tests can be based on the analysis of one or more specific markers by flow cytometry, fluorescent microscopy and/or qPCR. Biological activity (potency) can be measured using enzymatic assays or immunoassays linked to the relevant biological properties of the cell therapy product. We will present some efficient, optimised approaches developed at Quality Assistance for the characterisation of human mesenchymal stem cells