Advancing your pluripotent stem cell therapy research to clinical applications requires careful material selection because the quality of starting materials significantly impacts the properties of your final stem cell therapy product.
Gibco Cell Therapy Systems (CTS) products have been developed to ease the transition from stem cell therapy research to clinical applications by providing high quality GMP manufactured, commercial scale ancillary materials with a high degree of qualification, traceability, and regulatory documentation.
Our CTS media and reagents help minimize the risk of contamination and variability in your research. Extensive traceability documentation including FDA Drug Master Files and/or Regulatory Support Files support regulatory review, facilitating a seamless transition from research to commercialization. CTS products aim to reduce the time you spend from your initial discovery to approved therapy. The methods and controls used for ancillary material manufacturing conform with cGMP for medical devices, 21 CFR Part 820, USP <1043>, and Ph Eur 5.2.12.
We offer an extensive selection of stem cell research products with complementary CTS formulations. Our CTS products are used in commercially approved cell therapies as well as over 100 clinical trials and are backed by our professional regulatory support and over 30 years of GMP manufacturing experience.
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. Other approaches to ES or iPS cell therapy include 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 all the way to the clinic. We offer high-quality products across the pluripotent stem cell therapy workflow from reprogramming to differentiation. Most Gibco media and supplements 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.
First off-the-shelf reprogramming system manufactured in accordance with GMP requirements. The Invitrogen CTS CytoTune 2.1 kit offers high-efficiency Sendai delivery of reprogramming factors.
Based on the widely cited Essential 8 Medium, Gibco CTS Essential 8 Medium is the only globally available human pluripotent stem cell (hPSC) culture medium with components not directly derived from animals.
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.
Gibco CTS Essential 6 Medium is a xeno-free, feeder-free, cGMP-manufactured medium which supports the spontaneous or directed differentiation of human pluripotent stem cells (PSCs) and the reprogramming of somatic cells.
Gibco CTS Vitronectin (VTN-N) Recombinant Human Protein is a defined matrix for feeder-free culture of iPSCs.Designed in the laboratory of James Thomson, this recombinant protein is intended for use with the CTS Essential 8 culture system.
Gibco 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.
Gibco CTS Versene is a gentle non-enzymatic cell dissociation reagent for use in routine clump passaging of PSCs while maintaining viability over multiple passages.
For the cryopreservation and recovery of PSCs, the Gibco 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.
Gibco 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.
Gibco CTS KnockOut SR XenoFree Medium is a defined, xeno-free serum replacement based on the traditional KnockOut Serum Replacement, which has been cited in more than 2,000 publications and trusted for over 20 years.
We offer full customization options to help meet your unique specifications for any project. Flexibility is yours in creating your own Gibco custom cell culture medium