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Stemedica - BioSmart Technology
Stemedica’s manufacturing technology is not Stemedica’s only advantage. Our cells undergo a battery of tests, monitoring and analysis to ensure the highest-quality cells that will operate predictably under clinical, pre-clinical, or research conditions.
During manufacturing, each of Stemedica’s stem cell products is thoroughly analyzed and both gene and protein profiles are developed. Prior to shipment, Stemedica documents the batch-to-batch consistency and reproducibility of the cells. This documentation is provided with each shipment, to allow for easy traceability from manufacturing to eventual use.
Our cells undergo an extensive array of tests designed to ensure the cell’s safety and potency. This includes testing for infectious disease, acute and chronic toxicity, and tumorigenicity, all performed by independent laboratories. Furthermore, extensive batch testing ensures that there is no variation from product specifications.
Additionally, Stemedica’s proprietary master banking processes ensure cell preservation, thereby enabling us to ship cell products to approved clinical sites throughout the globe.
Stemedica has developed and executed a proprietary platform — BioSmart Technology™— for manufacturing non-embryonic allogeneic progenitor cells. This platform provides a competitive advantage in its ability to manufacture a reproducible and scalable pipeline of new product candidates that address major unmet medical conditions.
Stemedica manufactures its progenitor cells in a low-oxygen, low-tension environment. This type of manufacturing process is responsible for many of the benefits of our progenitor cells, including enhanced proliferation, high migratory ability, insignificant or no HLA-DR antigen expression and engraftment characteristics.
The BioSmart Technology™ manufacturing platform replicates the natural inside-the-body “micro-niche” environment from which cells originate, while the low-oxygen atmosphere further replicates the ischemic clinical conditions under which progenitor cells may be expected to proliferate. This hypoxic manufacturing process has other advantages as well. By keeping the cells in this low oxygen, low tension environment, they are protected from external exposure to normal oxygen and other disruptive and damaging elements.
Stemedica’s proprietary GMP manufacturing technology is not Stemedica’s only competitive advantage. Our cells undergo a battery of tests, monitoring and analysis to ensure the highest-quality cells. Each batch of Stemedica’s progenitor cells is thoroughly analyzed to meet lot release specifications. In addition, representative lots undergo an extensive array of tests designed to ensure the cell’s safety. This includes independent testing for infectious disease, acute and chronic toxicity, and tumorigenicity.
Stemedica’s cell banking processes ensure adequate cryopreservation, thereby enabling us to store cells long term and ship them to approved clinical sites throughout the globe.