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