Abstract
Human embryonic stem cell (hESC)-derived cellular products have been considered as promising candidates for cell replacement therapy for multiple degenerative diseases. At the Center of Biomedicine and Genetics (CBG), we have manufactured under cGMP numerous hESC-differentiated products including neuron stem cells (NSC), neuronal progenitor cells (NPC), retinal pigment epithelium (RPE) cells, dopaminergic neurons and cardiomyocytes intended for pre-clinical and clinical studies. Specifically, cardiomyocytes are produced through hESC differentiation procedure utilizing adherent and notably suspension culture systems. Prior to their release for clinical application, cardiomyocytes must be thoroughly tested for their identity and purity. We have developed a systematic approach to characterize hESC-derived cardiomyocytes using assays such as real-time quantitative polymerase chain reaction (RT-qPCR) and flow cytometry. The development and qualification of each assay involve the selection and banking of positive and negative controls, selection and banking of critical reagents, determination of assay conditions, qualification of assay, and generation of assay qualification report and standard operating procedure (SOP). We will also examine a number of critical factors including assay specificity, sensitivity, assay controls, and establishment of assay specifications.
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