sanostem

  • 1615 South Street, 93304

Manufacturing

Manufacturing

Manufacturing

Clinical grade stem cells were all produced in the California State Department of Public Health Food and Drug Branch (FDB) approved 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 SanoStem.

BioSmart Technology™

All the progenitor stem cells produced were greatly benefited from the exclusive patented BioSmart TechnologyTM:

SanoStem 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 SanoStem is carefully examined during production, and gene and protein profiles are created. SanoStem 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, SanoStem’s exclusive master banking procedures guarantee cell preservation, allowing us to deliver cell products to authorized clinical locations across the world.

Manufacturing

Phase 1/2 clinical grade cell products are available from our San Diego, California, cell production facility. The California State Department of Public Health Food and Drug Branch (FDB) has granted the Sanostem facility a license to generate cells for use in human clinical trials and cGMP (Current Good Manufacturing Practices) compliance. Sanostem adheres to stringent safety measurement and quality control procedures, including FDA guidelines for industry to control for tumorigenicity, acute and chronic toxicity, and infectious illnesses.

BioSmart Technology™

Our progenitor cells benefit greatly from our exclusive BioSmart TechnologyTM:

Sanostem 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 Sanostem is carefully examined during production, and gene and protein profiles are created. Sanostem 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, Sanostem’s exclusive master banking procedures guarantee cell preservation, allowing us to deliver cell products to authorized clinical locations across the world.
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