Both grades are manufactured under the same environmental conditions and following the same protocols. The Clinical grade material is subjected to more robust release testing and batch record documentation as indicated by the information provided on the certificate of analysis.  

Data demonstrate that Stemulate is generally suitable at an equivalent concentration of FBS or AB Serum depending on the cell type. Studies have been published that indicate a reduction of hPL concentration is possible and has been reported as effective down to 0.5%.

Clinical-grade Stemulate undergoes performance testing in cell culture as part of the release criteria to qualify each lot. The product must perform standard cell expansion following our growth verification assay.  Growth factor data is not collected per lot nor is it a determinant of lot release.  

30 months from the date of manufacture at -20C storage.

Yes. Stemulate is used in multiple clinical studies across the globe.

Ex vivo expansion of cells such as MSCs, ASCs, T Cells, etc. Please connect with us to learn which Sexton hPL is right for your application. 

Yes. We are ISO9001:2015 certified.

ll Stemulate products, Research and Clinical grade are supplied with a CoA upon purchase  
– Research grade Stemulate CoA provides sterility information  
o Endotoxin, Mycoplasma, Sterility (BacT)  
– Clinical or GMP compliant Stemulate provides all release criteria data and information