Induced Pluripotent Stem Cell (iPSC) Media and Reagents
for Cell Therapy

Induced pluripotent stem cells (iPSCs) and embryonic stem cells (ESCs) , sometimes collectively referred to as pluripotent stem cells (PSCs), are cells that have the ability to renew themselves indefinitely and differentiate into almost any cell type when exposed to the right microenvironment. These unique properties enable the application of induced pluripotent stem cells and embryonic stem cells in disease modeling, drug discovery, drug toxicity testing, and cell therapy. Strikingly, most embryonic stem cell and induced pluripotent stem cell applications have the potential to improve human health, none more directly so than ESC or iPSC therapy. The most intuitive approach for ES or iPS cell therapy is to transplant PSC-derived cells for the direct replacement of damaged or degenerated cells or tissue. However, there are many other approaches to ES or iPS stem cell therapy such as transplanting PSC-derived cells that then release signals triggering endogenous repair mechanisms.

At Thermo Fisher Scientific, we support the development of your human embryonic stem cell therapy or induced pluripotent stem cell therapy from the earliest stages of research and all the way to the clinic. We offer high-quality products across the iPS cell therapy workflow from reprogramming to differentiation. Most Gibco media and supplements for culture and differentiation are manufactured under GMP conditions at sites that use methods and controls that conform to current Good Manufacturing Practices (cGMP) for medical devices. These manufacturing sites are ISO 13485– and ISO 9001–certified, and the rigorous practices we adhere to at these sites help ensure the consistency, reliability, and high quality of a wide variety of iPSC therapy workflow reagents.

To further help you maximize the potential of your research and streamline your transition to the clinic, we offer Gibco Cell Therapy Systems (CTS) equivalents for many of our research-use products. In addition to GMP manufacturing, Gibco CTS products undergo quality control testing and are accompanied by appropriate documentation so you can transition your cell therapy to the clinic with confidence.

• Scalable manufacturing under GMP conditions—products manufactured under 21 CFR Part 820 Quality System Regulation for medical devices and ISO 13485-certified manufacturing site, with the ability to scale up and accommodate growing needs
• Quality control testing and regulatory documentation—sterility and endotoxin testing as well as full traceability for raw materials, with Drug Master File available upon request
• Designed for a seamless transition from research to clinic—serum-free, xeno-free or animal origin–free formulations with cell therapy specific intended use statements and complementary research use reagents

*Adherence to supplier related responsibilities of USP<1043>

Using Applied Biosystems TaqMan® hPSC Scorecard Panel analysis, Gibco CTS Essential 8 Medium and research-use-only Essential 8 Medium were shown to support comparable expression of PSC markers and lineage markers in undifferentiated PSCs and PSC-derived embryoid bodies.

CTS RevitaCell Supplement (100X) is an animal-origin-free, chemically defined supplement used with PSCs for post-thaw recovery or in combination with CTS Essential 8 Medium for single cell passaging. To minimize both the loss of cell viability and differentiation of PSCs, use the CTS PSC Cryopreservation Kit.

• Improved cell survival—provides high cell viability post-single cell passaging and post-thaw
• Contains higher specificity inhibitor—includes a higher specificity ROCK inhibitor, coupled with antioxidants and free radical scavengers to minimize impact of stress on cells
• Simplifies transition to clinic—animal-origin-free

CTS Versene is a gentle non-enzymatic cell dissociation reagent for use in routine clump passaging of PSCs while maintaining viability over multiple passages.

• Designed for cell therapy applications—manufactured using methods and controls that conform to cGMP for medical devices, 21 CFR Part 820
• Seamless transition from bench to clinic—same formulation as RUO Versene but with additional characterization and quality control testing
• Facilitates regulatory filings—full documentation traceability and FDA Drug Master File are available

For the cryopreservation and recovery of PSCs, the CTS PSC Cryopreservation Medium and CTS RevitaCell Supplement minimize the loss of cell viability and maximize post-thaw recovery when used in combination. Both reagents are included in the CTS PSC Cryopreservation Kit.

• Provides efficient recovery—routinely achieves higher viability than traditional methods of cryopreservation
• Offers consistency—chemically defined media maintains normal morphology, pluripotency, and karyotype of PSCs
• Reduces variability—optimized reagents minimize the causes of genetic instability of PSC

The CTS PSC Cryopreservation Medium is a xeno-free solution for the cryopreservation of pluripotent stem cells (PSCs). Both CTS PSC Cryopreservation Medium and CTS RevitaCell supplement are included in the CTS PSC Cryopreservation Kit that helps minimize loss of cell viability and maximize post-thaw recovery.

• Delivers higher recovery efficiency—efficient recovery and higher viability than traditional methods of cryopreservation
• Provides versatility—compatible with clump and singe cell passaged PSCs cultured in a variety of media systems
• Offers ease of use—provided as a ready-to-use , complete solution with no required additions of enhancing reagents