Long-term maintenance of PSC cultures

Advancing your induced pluripotent stem cells or human embryonic stem cell therapy research to clinical applications requires careful material selection because the quality of starting materials significantly impact the properties of your final stem cell therapy product. Gibco 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. In an effort to help you maximize the potential of your stem cell research and therapy, and simplify the transition to clinic-ready processes, we offer an extensive selection of research use 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.


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. 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 FDA-registered 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.


Translate your research to the clinic with Cell Therapy Systems Products

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 extensive safety 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 and USP 1043* at an ISO 13485-certified manufacturing site, with the ability to scale up and accommodate growing needs
  • Extensive safety testing and regulatory documentation—sterility, endotoxin, and adventitious agent 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>

Invitrogen CTS CytoTune-iPS 2.1 Sendai Reprogramming Kit

Gibco CTS CytoTune iPS 2.1 Sendai Reprogramming Kit

First off-the-shelf reprogramming system manufactured in accordance with GMP requirements. 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—extensive testing and documentation, including an FDA Drug Master File, to support your 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
Efficient reprogramming from adult human dermal fibroblasts, T cells, and CD34+ cells. These data demonstrate that the CytoTune-iPS 2.1 kit can be used to successfully reprogram human dermal fibroblasts (HDFa), T cells, and CD34+ cells.

Gibco CTS Essential 8 Medium

Gibco CTS Essential 8 Medium

Based on the widely cited Gibco Essential 8 Medium, Gibco CTS Essential 8 Medium is the first globally available human- and animal origin–free culture medium for human pluripotent stem cells (hPSCs) and is designed to meet international regulatory requirements for cell therapy.

  • Reduces risk—animal- and human origin–free and subject to rigorous safety testing
  • Helps enable 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.

Gibco CTS Vitronectin (VTN-N) Recombinant Human Protein

Gibco CTS Vitronectin (VTN-N) Recombinant Human Protein

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—recombinant matrix reduces variability and 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

Gibco CTS RevitaCell Supplement

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 with extensive safety testing

Gibco CTS Versene

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 safety testing, including adventitious agents
  • Facilitates regulatory filings—full documentation traceability and FDA Drug Master File are available

Gibco CTS PSC Cryopreservation Kit

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

Gibco CTS PSC Cryopreservation Medium

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—achieves 50% 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

Gibco CTS KnockOut SR XenoFree Medium

Gibco CTS KnockOut SR XenoFree Medium

CTS KnockOut SR XenoFree Medium is a defined, xeno-free serum replacement based on the traditional Gibco 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 intended for ex vivo tissue and cell culture processing applications
Maintenance of pluripotency using CTS KNOCKOUT SR XenoFree Medium
Maintenance of pluripotency using CTS KNOCKOUT SR XenoFree Medium. Following 10 passages in either KSR (left lane) or KSR XenoFree CTS (right lane) on HFF attached with CELLstart substrate, BG01v gene expression was examined (top). Gene expression of embryoid bodies generated from the same P10 BG01v/HFF cultures (bottom).

Gibco CTS KnockOut DMEM and Gibco CTS KnockOut DMEM/F12

Gibco CTS KnockOut DMEM and Gibco 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
For more information about neural lineages, see Neural Media and Reagents for Cell Therapy

Gibco Cell Therapy Systems (CTS) growth factors

Gibco Cell Therapy Systems (CTS) Growth Factors

Gibco CTS growth factors help enable you to easily qualify reagents during your transition from research applications to clinical applications. CTS products are supplied with harmonized documentation such as Certificates of Analysis and Certificates of Origin.

CTS offers high-quality growth factors and cytokines for T cell, stem cell and dendritic cell applications.

  • High biological activity—more results with less protein
  • High purity—no interference from other proteins or contaminants
  • Quality standards—manufactured under ISO 13485 Quality Standard

Resources

  • Cell Therapy Learning Center
    This collection of resources will help you gain a better understanding of cell therapy research
  • Cell Therapy Brochure
    Learn about our solutions to help you achieve your cell therapy goals from research to commercialization
  • CTS Brochure
    Learn more about our Cell Therapy Systems product offerings with our CTS brochure
  • Selection Guide
    Get help choosing cell therapy products for your cell type
  • Pluripotent Stem Cell Guidebook
    Our wide range of products and services allows you to simplify your workflow and provides you with more control, allowing for faster, more efficient systems.

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Related Products

Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.