A major obstacle in producing clinically relevant hMSCs is the lack of quantifiable protocols for evaluating trilineage differentiation. Current assessments rely on qualitative staining. To shift this from informational to a product release specification, GMP-compliant assays for differentiation need to be developed.
The project will utilize a qRT-PCR method to assess osteogenic, adipogenic, and
chondrogenic differentiation in a GMP test. Once the parameters of these assays are established, the SOPs and Batch Records will then be tech transferred (TT) to a Contract Testing Organization (CTO) for QC testing of GMP hMSCs.
GMP compliant assays for human mesenchymal stem cell (hMSCs) differentiation.
CQAs for product release specification rather than 'for information only.'
Methods developed will be used to draft standards for differentiation with the Standards Coordinating Body for the entire field of adult stem cell research.
By implementing quantitative assays for trilineage differentiation, an organization could reduce variability in GMP quality control by converting qualitative methods into measurable standards, enabling consistent product specifications and advancing technical standards for the adult stem cell field.
Developed a workflow for differentiating hMSCs and identifying specific gene markers for osteogenic, chondrogenic, and adipogenic differentiation.
Verified gene markers across multiple MSC donors, labs, and operators.
Created a cGMP-compatible protocol to quantitatively analyze hMSC differentiation in 14 days, reducing time and cost compared to qualitative assays.
Takacs, J., Adlerz, K., Hooker, B., Rowley, J., & Ahsan, T., Quantitative Trilineage Differentiation QC Assays for cGMP Manufacturing of Human MSCs, 22nd American Society of Gene and Cell Therapy Annual Meeting, Washington, DC, April 29, 2019.
Hooker, B., Quantitative Trilineage Differentiation Assays for cGMP Manufacture of Human Mesenchymal Stem/Stromal Cells, NIIMBL National Meeting, Washington, DC, June 28, 2019.
Quantitative Trilineage Differentiation Assays for cGMP Cell Manufacturing of Human Mesenchymal Stem Cells (PC1.0-039), NIIMBL Member Forum, Virtual, March 26, 2020.
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RoosterBio Inc
Carnegie Mellon University
Tulane University
