Advancing your therapeutic mesenchymal 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 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. In an effort to help you maximize the potential of your adult stem cell therapy research and simplify the transition to clinic-ready processes we offer an extensive selection of research use mesenchymal stem cell research products with complementary CTS formulations for MSC clinical research and commercial applications.
CTS products are high quality and are a trusted source for MSC clinical research. 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.
Mesenchymal stem cell therapy: workflow solutions
Mesenchymal stem cells (MSCs), also arguably known as stromal cells, are present in many tissues and are most known for their capacity to differentiate into specialized cells developing from mesoderm, namely osteoblasts, adipocytes and chondrocytes. Advancements in mesenchymal stem cell (MSC) research continue to shed light on how these multipotent stem cells may be used in various clinical applications. Preclinical and clinical adult mesenchymal stem cell therapy applications include immunomodulatory therapies (i.e., prevention of graft-versus-host disease or treatment of Crohn’s disease), autologous or allogeneic immunochemotherapies, and cell replacement therapies for mesenchymal tissues such as bone and cartilage. For more than a decade, we have provided key resources to address challenges in your stem cell workflow for your MSC clinical research. Designed to work together, our portfolio of mesenchymal stem cell products and services is designed to support and accelerate your path from discovery to the clinic.
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, 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 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>
CTS StemPro MSC SFM
Gibco CTS StemPro MSC serum free medium (SFM) is specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs) and human adipose-derived stem cells (ADSCs).
- Enables superior human MSC growth and increased consistency compared to classical serum-supplemented medium (DMEM + 10% FBS)
- Using CTS StemPro MSC SFM, human MSCs can be expanded beyond 5 passages while still maintaining their trilineage mesoderm differentiation potential
- Human MSCs grown in serum-supplemented media can be transitioned directly into CTS StemPro MSC SFM with little or no adaptation required
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
CTS CELLstart Substrate
Gibco CTS CELLstart Substrate is a defined substrate developed for stem cell attachment under serum-free conditions that contains only components of human origin (xeno-free).
- Can be used for MSC, NSC, and PSC attachment under serum-free conditions
- Defined formulation provides improved lot consistency compared to animal-origin matrices
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.
The CTS product line includes 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
Reagents for stem cell therapy research
See below for the extended list of reagents needed for stem cell maintenance and expansion. Gibco CTS GlutaMAX-1 is added to the Gibco CTS KnockOut SR XenoFree complete medium, and Gibco CTS TrypLE Select is an AOF reagent used for gentle cell dissociation.
CTS TrypLE Select
A non-animal alternative for porcine trypsin, Gibco CTS TrypLE Select is a recombinant enzyme derived from microbial fermentation. The CTS product line enables you to reduce your burden in qualifying reagents during your transition from research applications to clinical applications.
- Non-animal or human origin
- Reduced risk of viral or prion contamination
- Removal kinetics and recovery viability comparable to porcine trypsin
- Demonstration of activity on multiple cell lines, including strongly attached lines
- Stable at room temperature (15 to 30°C) for up to 6 months
- Manufactured using dedicated, autoclaved or disposable equipment
CTS DPBS, without calcium chloride, without magnesium chloride
Gibco CTS DPBS, without CaCl2, without MgCl2 is formulated to offer these benefits:
- Provides an environment that maintains the structural and physiological integrity of cells in vitro
- Contains high-quality materials suitable for use in clinical research studies
- Manufactured in state-of-the-art GMP, ISO certified facilities to ensure the highest quality and consistency for reproducible results every day.
- Intended use labeling "For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration into humans or animals."
CTS GlutaMAX I, L-alanyl-L-glutamine
Gibco CTS GlutaMAX I is a dipeptide substitute for L-glutamine and can be used as a direct substitute for L-Glutamine at equimolar concentrations in mammalian and stem cell culture with minimal or no adaptation. The CTS product line enables you to reduce your burden in qualifying reagents during your transition from research applications to clinical applications.
- Animal Origin Free
- GMP Manufactured to help ensure manufacturability and traceability