Manufacturing of therapeutic regenerative cellular and cell-free products requires a wide range of quality control to certify the identity, quality, and safety of the cells. Here we describe the Stemell quality control process to heighten the manufacturing of our StemL™ product lines.
- Carefully count cells with a state-of-the-art device purchased by Stemell to deliver our best services and products to our medical professionals and patients.
- Analyze the cells using a laser-impedance-based biophysical technology machine.
- Sort cells by targeted biomarkers’ detection.
- Use a state-of-the-art automated system to count and monitor precisely red blood cells; hemoglobin B; and white blood cells such as T-cells, B-cells, etc. in order to make sure our samples are not contaminated with any red blood cells or granulocytes that can cause body immune rejection and a series of life-threatening emergencies during transplant. Due to our unique technology, we are able to remove 98% to 100% of HGB and red blood cells from the samples.
As a result, Stemell monitors the process precisely via three steps:
- Use an FDA-approved automated device to determine the hemoglobin and hematocrit levels.
- Run multiple assays, which will measure cell potency, identity, quality, and integrity.
- Analyze the cell population by sorting the cells.
We set up additional epigenetic assays to confirm consistency of our manufactured StemL™ products and distinguish these products from other adherent stromal cells such as mesenchymal stromal cells (MSC). All Stemell products are uncultured, serum-free, xeno-free, bovine–free, and screened for any microbial and fungal pathogens.
Stemell’s allograft products are manufactured diligently under sterile conditions and in a fully protected environment to enhance product safety from microbiological and viral transmission or any other contaminations. All products are manufactured in fully certified Class 100 clean rooms. Our trained technicians operate under good laboratory practices, good tissue practices, and good manufacturing practices, as well as regulations and requirements, in order to make sure the company maintains the highest standards in concert with our vision and quality promises.
Stemell focuses on three critical elements as far as quality:
- Viability of the product (cellular products)
- Safety of the product
- Sterility of the product