Quality Control During Manufacture of a Stem Cell Therapeutic

摘要

Development and manufacturing of a therapeutic stem cell product requires extensive quality control (QC) to ensure the identity, quality, and safety of the cells. Here, we describe our QC pipeline to optimize the manufacturing of our MultiStem adherent stem cell product, which is in clinical trial testing for stroke, acute myocardial infarction, inflammatory bowel disease, graft versus host disease, and solid organ transplantation. Screening for growth, marker expression, immunosuppression, and multipotent differentiation — in combination with "-omics" screening for gene expression, DNA methylation, and miRNA patterns — provides a comprehensive characterization of the cells, which facilitates further optimization of the manufacturing process.