Cell Therapy Systems (CTS) tools, reagents, and services, support cell therapy research and further manufacturing of cell-, gene-, and tissue-based products. Our CTS T-cell culture media and reagents help minimize the risk of contamination and variability in your research and provide extensive traceability documentation, including FDA Drug Master Files and/or Regulatory Support Files to support regulatory review, thus facilitating a seamless transition from research to commercialization.
We offer tailored T-cell media, dendritic cell culture media, and supplements for a variety of immune cell types. Ongoing efforts in innovation allow us to offer media specific for the growth and expansion of human T-lymphocytes, for example, CTS OpTmizer Pro Serum Free Medium (SFM) for use in allogeneic cell therapies. 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 and USP <1043>, Ph Eur 5.2.12.
For more information about our product offerings, ordering information, and customer support, access our Cell Therapy Solutions brochure. If you’re interested in a custom CTS product, please send us an inquiry.
A compact, flexible closed cell processing system, designed to streamline and expedite your cell therapy development, that enables:
A closed, scalable electroporation system for GMP-compliant cell therapy manufacturing
CTS Dynabeads CD3/CD28 mimic in vivo T-cell activation via antigen-presenting cells. This gentle and efficient technology provides a trusted technology platform from which the beads can be used to isolate T-cells and provide both the primary and co-stimulatory signals required for activation and expansion (Annu Rev Immunol 32:189 (2014); Nat Med 21:914 (2015); Mol Ther 15:355 (2007).) The Novartis chimeric antigen receptor T-cell (CAR-T) cell therapy, Kymriah™ (tisagenlecleucel, formerly CTL019), is the first FDA-approved CAR-T immunotherapy, and uses specifically developed Cell Therapy Systems (CTS) Dynabeads technology.
Optimized for regulatory T-cells (Tregs), Gibco CTS Dynabeads Treg Xpander provides a more specific and higher-fold expansion of Tregs with superior cell yields and suppression of conventional T-cells, which is essential for the treatment of autoimmune disease.
The Gibco CTS DynaMag Magnet facilitates efficient isolation of T-cells in conjunction with CTS Dynabeads CD3/CD28 magnetic beads in closed, sterile blood bags (Cytotherapy16:619 (2014)).
The CTS LV-MAX Lentiviral Production System offers a scalable high-titer lentiviral vector production platform. This system includes HEK 293–derived suspension cells, serum-free media, proprietary transfection reagent, supplement, and enhancer. It can produce up to 10X more lentivirus, cutting costs by more than half compared to using polyethyleneimine (PEI)–based lentiviral production methods.
Our GMP-banked CTS Viral Production Cells are derived from the human embryonic kidney (HEK) 293 cell line, and were adapted to suspension culture in a chemically-defined medium. These cells were developed to support cell and gene therapy applications, particularly intended for viral vector manufacturing. For more information on this cell line and our flexible licensing options, please contact email@example.com
Whether you’re working with an adherent or a suspension production system, lentiviral production can be a costly part of your overall operation. Our high-titer lentiviral production system comprises research use and GMP reagents to provide a cost-effective scalable solution for lentiviral vector production, from research through commercial manufacturing.
CTS Immune Cell Serum Replacement (SR) is designed to support expansion of in vitro cultured human immune cells such as T-cells. It is a defined xeno-free formulation, proven for clinical use, and designed to support expansion of in vitro cultured human T-cells, when added as a supplement to a basal cell culture medium such as Gibco CTS OpTmizer T Cell Expansion SFM or AIM V Medium.
NEW CTS OpTmizer Pro Serum Free Medium (SFM)
Improve central memory phenotype and cell growth for allogeneic T-cell therapies. Gibco CTS OpTmizer Pro SFM is a novel medium, developed for the growth and expansion of human T lymphocytes (e.g., CD4+, CD8+, polyclonal cells, or antigen specific T-cells) used in allogeneic cell therapies. CTS OpTmizer Pro SFM improves central memory phenotype and cell growth by shifting the cell’s metabolism. The result is a larger population of central memory cells in a shorter period of time.
Enhanced Design and Compatibility
Thermo Scientific Aegis5-14 Film allows compatibility with closed systems.
Thermo Scientific Aegis5-14 Film is a five-layer cast film produced in a cGMP facility. The outer layer is a polyester elastomer coextruded with an ethyl vinyl alcohol (EVOH) barrier layer and an ultra-low-density polyethylene product contact layer. Aegis5-14 Film is manufactured using no animal derived components.
A complete serum-free, xeno-free medium formulation proven for clinical success and specifically developed for the growth and expansion of human T lymphocytes. CTS OpTmizer T Cell Expansion SFM is now available without phenol red.
Gibco CTS AIM V Medium is a fully defined serum-free formulation for proliferation and/or manipulation of T cells, dendritic cells, and other primary or immortalized cells. It contains L-glutamine and is formulated with or without phenol red and antibiotics, making it ideal for research or manufacturing. Gibco CTS AIM-V Medium, without phenol red, without antibiotics, is now available in a flexible packaging format suitable for aseptic integration into your workflow through sterile welding, MPC quick connect, or Luer lock connections.
*Other aspects of USP <1043> will be the responsibility of the end-user to assess.Thermo Fisher Scientific cannot fulfill USP <1043> in regards to application and therapy-specific aspects (e.g., residual assessment and removal of the AM).
Our next-generation Cas9 protein is now available in a Cell Therapy System (CTS) formulation, CTS TrueCut Cas9 Protein, for large scale clinical research.
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
The Applied Biosystems PureQuant Assays offer an alternative to flow cytometry to identify and quantify B cells, monocytes, CD3+, CD4+, and CD8+ T-cells, regulatory T-cells (Treg), and T-helper cells (Th17) in a mixed population. These TaqMan® qPCR-based assay kits measure genomic DNA methylation at specific sites that serve as a unique cell type specific identifier. Assays include all reagents, standards, and controls.
Gibco Cell Therapy Systems CTS DPBS is the classical Dulbecco’s Phosphate Buffered Saline not containing calcium, magnesium, or phenol red. Gibco CTS DPBS, without calcium chloride, without magnesium chloride is now available in a flexible, closed system compatible packaging format.
CTS GlutaMAX supplement is an animal origin–free (AOF) dipeptide alternative to L-glutamine, with increased stability that improves cell health. CTS GlutaMAX supplement can be used as a direct substitute for L-glutamine at equimolar concentrations in mammalian and stem cell culture with minimal or no adaptation.
|Can I use CTS Growth Factors/Cytokines products for in vivo clinical use?||No. CTS Growth Factors/Cytokines cannot be used for direct in vivo applications. CTS products are intended for use as ancillary reagents used in the manufacturing process which includes a wash step prior to any in vivo application.|
|Can I use CTS Growth Factors/Cytokines in clinical trials?||Researchers are free to use these products in accordance with the Limited Use Label License (LULL) for early research-based clinical trials through Phase IIA. However, the proper regulatory approval is required before using CTS products in research-based clinical trials since they may require specific labeling and/or higher quality manufacturing standards.|
|Can I use CTS Growth Factors/Cytokines for commercial use?||Researchers are free to use these products in accordance with the Limited Use Label License (LULL), but commercial use is not allowed under general purchase of these products. Commercial access to these products may be available through a formal Supply Agreement under which we do not anticipate that there will be any additional licensing fees for these products. In all cases, it is the researcher’s responsibility to get approval from the appropriate regulatory authorities for labeling and intended use of these ancillary materials for your application beyond phase IIA trials.|
|Can I use CTS products for in vivo clinical use?||No. CTS products cannot be used for direct in vivo applications. CTS products are intended for use as ancillary reagents used in the manufacturing process which includes a wash step prior to any in vivo application.|
|Can I use CTS products in clinical trials?||Researchers are free to use these products in accordance with the Limited Use Label License (LULL) for early research-based clinical trials through Phase IIA. If there are LULL restrictions, an assessment of your intended use may be required. The proper regulatory approval is required before using CTS products in research-based clinical trials since they may require specific labeling and/or higher quality manufacturing standards.|
|Can I use CTS products for commercial use?||Researchers are free to use these products in accordance with the Limited Use Label License (LULL), but commercial use is not allowed under general purchase of these products. If there are LULL restrictions, an assessment of your intended use may be required. Commercial access to these products may be available through a formal Supply Agreement under which we do not anticipate that there will be any additional licensing fees for these products. In all cases, it is the researcher’s responsibility to get approval from the appropriate regulatory authorities for labeling and intended use of these ancillary materials for your application beyond phase IIA trials.|
|CTS OpTmizer Pro Serum Free Medium (SFM)|
|Does CTS OpTmizer Pro SFM contain any steroids/proteins?||CTS OpTmizer Pro SFM contains albumin and transferrin, but no steroids.|
|Can CTS OpTmizer Pro SFM be stored frozen for extended shelf life?||CTS OpTmizer Pro SFM should not be stored frozen.|
|Does CTS OpTmizer Pro SFM have a DMF?||Yes, CTS OpTmizer Pro SFM has all the traceability documentation—including Drug Master Files (DMF) and certificates of origin.|
|What populations of T cells has this product been verified to culture?||CTS OpTmizer Pro SFM is targeted for the expansion of CD3+CD4+ and CD3+CD8+ T-cells.|
|Are there any special considerations for adapting my protocols/current cells in culture to CTS OpTmizer Pro SFM?||The protocol for the use of CTS OpTmizer Pro SFM is identical to CTS OpTmizer T Cell Expansion SFM.|
|Is CTS OpTmizer Pro SFM compatible with GlutaMax?||This medium can be supplemented with GlutaMAX, with a recommended concentration of 2%.|
|What is the maximum cell density that CTS OpTmizer Pro SFM can support?||CTS OpTmizer Pro SFM has been used to support cell densities up to 5 x 106 cells/mL in a static plate and 9 x 107 cells/mL in a perfusion rocking bioreactor.|
|Can CTS OpTmizer Pro SFM be used with larger vessels?||CTS OpTmizer Pro SFM supports cell expansion in rocking bioreactors and has been tested up to 5 L volumes.|
Kymriah is a registered trademark of Novartis Pharmaceuticals Corporation.
Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.