Advancing your pluripotent stem cell therapy research to clinical applications requires careful material selection as the quality of starting materials significantly impacts the properties of your final stem cell therapy product.
At Thermo Fisher Scientific, we have developed Gibco Cell Therapy Systems (CTS) products across the pluripotent stem cell therapy workflow to ease the transition from discovery to commercial manufacturing. We offer high quality GMP manufactured, commercial scale ancillary materials with a high degree of qualification, traceability, and regulatory documentation.
- Scalable manufacturing under GMP conditions - Gibco media and supplements are manufactured in conformity with Good Manufacturing Practices (GMP) for medical devices, 21 CFR Part 820, and follow USP<1043> and Ph Eur 5.2.12, and our manufacturing sites are FDA-registered and ISO 13485- and/or ISO 9001-certified. Our investment in rigorous product manufacturing ensures the consistency, reliability, and high quality of PSC therapy reagents in combination with the ability to scale up and accommodate changing needs.
- Quality control testing and regulatory documentation - CTS media and reagents help minimize the risk of contamination and variability in your research with extensive safety testing, including sterility, endotoxin and mycoplasma. Full traceability for raw materials is also available, including Drug Master Files and/or Regulatory Support Files, and certificates of origin.
- Proven use for a seamless transition from research to clinic - We offer an extensive selection of serum-free, xeno-free, or animal origin–free formulations with cell therapy specific intended use statements and complementary research use reagents. Our CTS products have been used in over 200 clinical trials as well as in commercially approved cell therapies including FDA-approved CAR-T therapies and the first FDA-approved therapeutic cancer vaccine.
Featured products on this page:
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
Gibco CTS Xenon Electroporation System
A closed, scalable electroporation system for GMP-compliant cell therapy manufacturing
- High speed and large volume—transfect up to 2.5 x 109 T cells/25 mL in less than 25 minutes
- Scalable, proven performance and viability—up to 90% gene knockout with CTS TrueCut Cas9 Protein and 80% cell viability
- Process flexibility—user-programmable system enables you to create and optimize electroporation protocols for various cell types and payloads, from process development through commercial manufacturing
- Efficient nonviral transfection—can be used to deliver DNA, RNA, and protein payloads
- Closed-system processing—Xenon MultiShot Electroporation Cartridge helps enable sterile welding to PVC or C-Flex™ tubing
CTS CytoTune-iPS 2.1 Sendai Reprogramming Kit
The first off-the-shelf reprogramming system manufactured in accordance with GMP requirements, offering high-efficiency Sendai delivery of reprogramming factors.
- Xeno-free workflow—generate iPSC lines from both fibroblasts and blood for clinical research
- Regulatory support—traceability documentation, such as Certificate of Analysis and Certificate of Origin, available to support your regulatory filing
- 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 first globally available human pluripotent stem cell (hPSC) culture medium with components not directly derived from animals.
- Supports long-term iPSC culture—maintains iPSC marker expression and a normal karyotype over multiple passages
- Maintains differentiation potential—PSCs cultured in CTS Essential 8 Medium are able to generate cells of all three germ layers
- Helps reduce risk—based on the same fully defined and highly consistent eight-component formulation as RUO Essential 8 Medium but without components directly of animal or human origin
CTS Essential 6 Medium
Gibco CTS Essential 6 Medium is a xeno-free, feeder-free medium which supports the spontaneous or directed differentiation of human pluripotent stem cells (hPSCs) 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
- Supports differentiation and reprogramming—does not contain bFGF or TGFbeta
CTS Vitronectin (VTN-N) Recombinant Human Protein
Designed in the laboratory of James Thomson, Gibco CTS Vitronectin (VTN-N) Recombinant Human Protein is a defined matrix for feeder-free culture of pluripotent stem cells (PSCs) and is designed for clinical research.
- Animal origin–free—for reduced variability and contamination risk in PSC cultures.
- Optimized—intended for use with CTS Essential 8 Medium
- Consistent—supports seamless transition from RUO Vitronectin
- Traceable and controlled—documentation includes COO and COA; manufactured in compliance with ISO-13485
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.
- 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
- Offers consistency—formulated using animal-origin free and chemically defined materials
CTS Versene Solution
Gibco CTS Versene is a gentle non-enzymatic cell dissociation reagent for routine clump passaging of PSCs while maintaining viability over multiple passages.
- Maintain viability over multiple passages—PSCs passaged with this cGMP manufactured EDTA dissociation reagent maintain viability
- Seamless transition from bench to clinic—same formulation as RUO Versene Solution but with additional characterization and quality control testing
CTS PSC Cryopreservation Kit
The Gibco CTS PSC Cryopreservation Kit, which includes CTS PSC Cryomedium and CTS RevitaCell Supplement, minimizes the loss of cell viability and maximizes post-thaw recovery of PSCs.
- Provides efficient recovery—routinely achieves higher viability than traditional methods of PSC 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 PSCs
CTS PSC Cryomedium
Gibco CTS PSC Cryomedium is a xeno-free solution for the cryopreservation of PSCs. It also helps minimize loss of cell viability and maximize post-thaw recovery as part of the CTS PSC Cryopreservation Kit.
- 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
- Optimized—lower osmolarity as compared to traditional formulations improve maintenance of undifferentiated iPSCs
- Versatile—have been shown to support expansion and differentiation of a variety of stem cells, including iPSCs
- Tried and tested—cited in many publications, often used with CTS KnockOut SR XenoFree supplement
NEW CTS TrueCut Cas9 Protein
Our next-generation Cas9 protein is now available in a Cell Therapy System (CTS) formulation, CTS TrueCut Cas9 Protein, for large scale clinical research.
- Exceptional performance—consistently high performance in all tested cell lines, including >90% editing in iPSCs
- Higher stringency manufacturing—manufactured in compliance for Ancillary Materials for Cell, Gene and Tissue-Based Products
- Extensive safety testing—including sterility, endotoxin, mycoplasma, residual host nucleic acids, and proteins
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