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Clinical grade stem cells were all produced in the California State Department of Public Health Food and Drug Branch (FDB) approved Sano Stemedica facility, with a license to generate stem cells for use in human clinical trials under cGMP (Current Good Manufacturing Practices) compliance. Using stringent safety methods and quality control procedures, including FDA guidelines for industry to control for tumorigenicity, acute and chronic toxicity, and infectious illnesses, thus technology has been fully acquired by Sano Stemedica.
All the progenitor stem cells produced were greatly benefited from the exclusive patented BioSmart TechnologyTM
Sano Stemedica has created and implemented BioSmart TechnologyTM, a patented platform for producing non-embryonic allogeneic progenitor cells. The potential of this platform to provide a scalable and reproducible pipeline of novel product candidates that address significant unmet medical needs gives it a competitive edge.
Sano Stemedica uses a low-oxygen, low-tension environment to produce its progenitor cells. Numerous advantages of our progenitor cells, such as increased proliferation, strong migratory capacity, negligible or nonexistent HLA-DR antigen expression, and engraftment features, are caused by this kind of production procedure.
The low-oxygen atmosphere further mimics the ischemia clinical settings under which progenitor cells may be expected to grow, and the BioSmart TechnologyTM production platform replicates the natural inside-the-body “micro-niche” environment from which cells arise. There are other benefits to this hypoxic manufacturing method. The cells are shielded from normal oxygen and other dangerous and disruptive substances by being kept in this low oxygen, low tension environment.
Sano Stemedica’s competitive edge is not limited to its own GMP production technique. To guarantee the highest-quality cells, our cells go through a rigorous testing, monitoring, and analysis process. To satisfy lot release requirements, every batch of Sano Stemedica progenitor cells is carefully examined. Representative batches also go through a wide range of tests intended to guarantee the safety of the cell. This covers independent testing for tumorigenicity, acute and chronic toxicity, and infectious illness.
Because Sano Stemedica’s cell banking procedures guarantee proper cryopreservation, we are able to keep cells for an extended period of time and send them to authorized clinical locations across the world.
Sano Stemedica has many advantages than only its production process. Our cells go through a rigorous testing, monitoring, and analysis process to guarantee the best quality cells that will function consistently in pre-clinical, clinical, or research settings.
Every stem cell product produced by Sano Stemedica is carefully examined during production, and gene and protein profiles are created. Sano Stemedica records the cells’ repeatability and batch-to-batch consistency before shipping. Each shipment includes this paperwork to facilitate simple tracing from production to final use.
To guarantee their safety and effectiveness, our cells go through a rigorous battery of tests. This covers tumorigenicity, acute and chronic toxicity, and infectious disease testing, all of which are carried out by separate labs. Additionally, thorough batch testing guarantees that the product requirements won’t be altered.
Furthermore, Sano Stemedica’s exclusive master banking procedures guarantee cell preservation, allowing us to deliver cell products to authorized clinical locations across the world.