Reply To: Establishing iPSCs under GMP conditions

[UmaLakshmipathy]

Dear Lygia,

Last year we launched the first commercial reprogramming kit, “CTS CytoTune iPS 2.1 Sendai Reprogramming Kit”  specifically designed for clinical and translational use. 

https://www.thermofisher.com/order/catalog/product/A34546?SID=srch-srp-A34546

Our workflow approach to product development also means that compatible media and characterization solutions are integrated including our new CTS Essential 8 media and scalable molecular characterization tools, PluriTest, Scorecard and KaryoStat to confirm pluripotency and karyotypic stability.

https://www.thermofisher.com/us/en/home/life-science/stem-cell-research/induced-pluripotent-stem-cells/essential-6-8-medium/cts-essential-8-medium.html

https://www.thermofisher.com/us/en/home/life-science/stem-cell-research/induced-pluripotent-stem-cells/pluripotent-stem-cell-detection.html

These CTS products provides an efficient regulatory pathway to transition from research to translational research with confidence.  In addition to being manufactured according the GMP principles, these products come with regulatory expert support, extensive testing and traceablility documentation including Certificates of Analysis, Certificates of Origin and Drug Master Files.

Please do let me know if I can provide any additional information.

Uma