Performance Period: 10/22/2018 to 10/21/2020
Human Mesenchymal Stem Cells (hMSCs) are currently associated with over 1000 clinical trials (clinicaltrials.gov). As these studies progress to Phase 2 trials and beyond, more rigorous cGMP operations become required. Many investigators will then need to transfer production and quality processes to contract manufacturing and testing organizations. Production of clinically relevant hMSCs is presently hindered by the lack of objective methods for evaluating trilineage differentiation, a critical attribute of these cells. The current standard assessment of osteogenic, adipogenic, and chrondrogenic differentiation is based on qualitative staining. In order to shift this critical quality attribute from an “information only” characterization to a product release specification, GMP compliant assays for differentiation must be developed. Over the course of this effort, an analytical method will advance from Manufacturing Readiness Level (MRL) 4 to MRL 7.
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