Products for a smoother transition from research to clinic
Whether you’re developing a CAR-T therapy, another type of T cell immunotherapy, or working with other immune cell types, Gibco CTS products are the superior choice from research to clinic and beyond. 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, 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. 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 Immunotherapy solutions brochure Gibco CTS brochure and Cell Therapy Solutions brochure. If you’re interested in a custom CTS product, please send us an inquiry.
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Register for our next T cell webinar
Title: CAR-T Generation for Identity, Purity and Potency Assay Testing
Speaker: Tia Hexom, PhD, Field Applications Scientist, Cell Therapy, Thermo Fisher Scientific
Date: February 25th, 2020
Time: 9:00 a.m. PDT, 12:00 p.m. EDT
CTS Dynabeads CD3/CD28
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 costimulatory 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.
- Isolate, activate, and expand your T cells ex vivo with just one product
- Harvest 100–1,000 fold expanded T cells in just 9–14 days
- Recover T cells with properties comparable to in vivo–activated T cells
CTS Dynabeads Treg Xpander
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.
- Scalable technology for robust activation and expansion of Tregs
- Aseptically manufactured and ready for clinical trials and commercial manufacturing
- >800-fold expansion at day 14 following stimulation at day 0 and day 9
- Expressed high percentage of FoxP3, CCR7, CD62L, CD45RO and CD45RA, and central memory phenotype markers
CTS DynaMag Magnet
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)).
- Isolate bead-bound cells, for example for subsequent stimulation/expansion of T cells with CTS Dynabeads CD3/CD28 and for removal of the beads following the expansion protocol
- Ideal for magnetic isolation in closed, sterile blood bags and tubing systems
- Remove unwanted cell types by discarding the magnetic captured bead-bound cells
CTS LV-MAX Lentiviral Production System
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.
- Cost effective—reduce lentiviral vector production costs by up to 50%
- High titers—greater than 1 x 108 TU/mL (unconcentrated)
- GMP manufactured—seamlessly transition from research to commercial production
CTS Viral Production Cells
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 firstname.lastname@example.org
- Extensive documentation of cell line lineage
- Absence of SV40 large T antigen
- Supports >10 million cells/mL in chemically defined medium
Lentiviral production solutions
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)
CTS Immune Cell Serum Replacement (SR) is designed to support expansion of in vitro cultured human immune cells such as T cells. 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.
- Minimizes the supply and safety risks associated with human serum and can be used with the base media of your choice
- Supports expansion, efficacy and resistance of lentiviral gene-modified CAR T cells
- Supports T cell phenotype (CD4, CD8, and CD62L) similar to human serum
CTS OpTmizer T Cell Expansion SFM
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.
- Supports high density T cell culture
- Supports phenotype, function and viability similar to T cells cultured with conventional medium supplemented with human AB serum
- Now supplied in a 1L enclosed bag facilitating work in GMP environments
CTS AIM V Medium
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 clinical applications.
- Tested for adventitious agents
- FDA-cleared class II medical device
- Supports expansion of human dendritic cells and other immune cells, including CAR T cells
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
The Applied Biosystems PureQuant Assays offer an alternative to flow cytometry to accurately identify and quantify 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.
- Facilitates regulatory filings—shorten development timelines; established performance specifications following ICHQ2(R1) guidelines
- Proven technology—used for immune cell identification and quantification for over a decade
- Easily standardized—consistent results across multiple users, instruments, and sites
- Scheduling flexibility—run fresh cells, frozen cells or gDNA at your convenience
CTS DPBS without calcium chloride, without magnesium chloride
Gibco Cell Therapy Systems CTS DPBS is the classical Dulbecco’s Phosphate Buffered Saline not containing calcium, magnesium or phenol red.
- Provides an environment that maintains the structural and physiological integrity of cells in vitro
- Chemically defined and animal origin–free materials suitable for use in clinical research studies
|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.|
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.