Manufacturing of a therapeutic stem cell product requires wide range of quality control to certify the identity, quality, and safety of the cells. In this policy, we describe Stemell® QC process to heighten the manufacturing of our StemL™ product lines, 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 provides a complete characterization of the cells, which enables further optimization of the manufacturing process.
1.Carefully counting cells with a state of the art device purchased by Stemell® to deliver our dedications and full promises to our medical professions and patients.
2.Analyzing the cells using laser-impedance based biophysical technology machine.
3.Cell sorting by targeted biomarkers’ detection.
4.Using a state of the art automated System to count precisely red blood cells, white blood cells such as T-cells, B-cells and etc.
5.In order to make sure our samples are not contaminated with any red blood cells or granulocyte which can cause body immune rejection and series of life threatening emergency, during transplant (Normal range 1-4%).
As the result, Stemell® monitor the process precisely by 3 steps:
1.Using a FDA approved automated device to determine the hemoglobin and hematocrits levels.
2.Running multiple assays, which will measure Stem Cell Potency, identity, quality and integrity.
3.Analyzing the cell population by sorting the cells.
We set up additional epigenetic assays to confirm consistency of our manufactured StemL™ products and distinguish this product from other adherent stromal cells such as mesenchymal stromal cells (MSC). In the context of biosafety, to demonstrate a normal stem cell karyotype, Stemell® analyzes copy number variation (CNV). Cultured cells are compared with donor-derived, non-expanded, mononuclear cells on SNP arrays, and the resulting data are analyzed for genomic insertions or deletions at a resolution of 50 kb. Altogether, these assays can confirm proper stem cell identity, stem cell properties, and biological activity relevant to therapeutic action.