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.
- 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
Featured Cell Therapy System products on this page:
NEW Gibco CTS Rotea™ Counterflow Centrifugation System
A compact, flexible closed cell processing system, designed to streamline and expedite your cell therapy development, that enables:
- Process flexibility—user-programmable software enables you to create and optimize a broad range of protocols for cell separation, washing, and concentration
- High cell recovery and viability—gentle processing enables >95% cell recovery while maintaining cell viability
- Low output volumes—proprietary technology can deliver as little as 5 mL of concentrate
- Research through commercial manufacturing—the closed single-use kit enables sterile processing, and an OPC-UA interface enables connectivity to a 21 CFR Part 11-compliant system
Enabling pluripotent stem cell therapy research
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.
CTS CytoTune-iPS 2.1 Sendai Reprogramming Kit
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.
- Xeno-free workflow—generate iPSC lines from both fibroblasts and blood for clinical research
- Regulatory submission support—documentation such as a regulatory support file to support regulatory submission
- Designed with transition in mind—complimentary research-use CytoTune iPS 2.0 Sendai Reprogramming Kit helps facilitate a seamless translation to the clinic
CTS Essential 8 Medium
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.
- Helps reduce risk—fully defined
- Enables seamless transition—same fully defined and highly consistent eight-component formulation as RUO Essential 8 Medium but with animal origin–free components
- Supports long-term iPSC culture—maintains iPSC marker expression, trilineage differentiation potential, and a normal karyotype over multiple passages
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 Essential 6 Medium
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.
- Provides a flexible format—suits different applications and various cell types
- Simplifies the transition from bench to clinic—contains the same six essential components as RUO Essential 6 Medium, and with its cGMP manufacturing process, this formulation helps minimize variability
CTS Vitronectin (VTN-N) Recombinant Human Protein
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.
- Animal origin–free—microbial expression recombinant matrix helps reduce variability and viral contamination risk in iPSC cultures
- Optimized—VTN-N variant has been shown to support human iPSC attachment and survival better than wild type vitronectin
- Supports pluripotency—able to maintain pluripotency, normal growth characteristics, trilineage potential and normal karyotype after extended culture
CTS RevitaCell Supplement
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.
- 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 formulation
CTS Versene Solution
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.
- 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 Solution but with additional characterization and quality control testing
CTS PSC Cryopreservation Kit
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.
- 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
CTS PSC Cryomedium
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.
- 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
CTS KnockOut SR XenoFree Medium
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.
- Supports pluripotency—able to maintain the pluripotency, normal morphology, and karyotype of hPSCs
- Versatile—can also be used for cryopreservation, derivation, and differentiation of iPSCs
- Designed for your applications—a first-to-market, xeno-free iPSC product
CTS KnockOut DMEM and CTS KnockOut DMEM/F12
Your choice of chemically defined human- and animal origin-free basal media for pluripotent stem cell culture. Based on traditional DMEM and DMEM/F12 formulations, these basal media are:
- Optimized—lower osmolarity compared vs. traditional formulations improve maintenance of undifferentiated iPSCs
- Versatile—have been shown to support expansion and differentiation of a variety of stem cells aside from iPSCs
- Tried and tested—cited in many publications, often used with CTS KnockOut SR XenoFree Medium
Custom Media
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
- Add or remove components
- Change a concentration
- Switch packaging
- Select from cGMP or non-GMP
- Choose QC tests
