Cell Therapy Systems Immunotherapy—T-Cell and Dendritic
Cell Products

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.

• 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

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.

Key features:

• Scalable technology for robust activation and expansion of Tregs
• Aseptically manufactured and ready for clinical research 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

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

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

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 outlicensing@thermofisher.com

• Extensive documentation of cell line lineage
• Absence of SV40 large T-antigen
• Supports >10 million cells/mL in chemically defined medium

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.

• 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 persistence of lentiviral gene-modified CAR T cells
• Supports T-cell phenotype (CD4, CD8, and CD62L) similar to human serum
• Available in versatile BPC formats for integration into a closed-system workflow

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.

Learn more

Features

• Serum-free and xeno-free medium
• Supports high density cultures in static cultures
• Supports T-cell activation using Dynabeads magnetic beads, soluble antibodies, and stimulatory antibody-presenting cell protocols
• New Aegis5-14 film and bag design allows compatibility with closed systems

Benefits

• The media maintains central memory T-cells further into expansion and is well suited for longer workflows (>15 days)
• Modest increases in central memory cells at early stage in the expansion protocol result in larger cell yields at harvest
• Capable of achieving the same number of cells in a shorter duration
• Ideally suited to the production of allogeneic therapies

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

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.

• Adherence to supplier-related responsibilities of USP <1043>*
• Approved for use in multiple clinical trials globally
• Closed system compatible: flexibility to sterile weld or aseptically connect to closed systems

*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.

• Exceptional performance—consistently high performance in all tested cell lines, including >90% editing in T cells
• Higher stringency manufacturing—manufactured in compliance to the standards for Ancillary Materials for Cell, Gene and Tissue-Based Products
• Extensive safety testing—including sterility, endotoxin, mycoplasma, residual host nucleic acids, and proteins

   See data

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. 

• 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

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.

• 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
• Closed system compatible–flexibility for sterile welding, MPC quick connect, or Luer lock connections to integrate into your workflow

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.

• Minimizes toxic ammonia build-up—unlike L-glutamine, GlutaMAX Supplement does not spontaneously break down to form ammonia. This prevents waste build-up and maintains a fresh supply of L-glutamine during long-term culture
• Improves growth efficiency and performance of mammalian cell cultures—lower levels of ammonia results in improved cell viability; in addition, culture conditions are more controlled due to the consistent concentration of GlutaMAX supplement that is not possible with L-glutamine
• Remains stable across a wide range of temperatures—CTS GlutaMAX supplement retains full functionality at room temperature or 2–8°C, for convenient storage and handling