Gibco CTS products for immunotherapy

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, 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.

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Learn more about the latest featured member of the product family—CTS OpTmizer Pro Serum Free Medium (SFM)

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.

당사는 세포 치료 연구뿐만 아니라 세포, 유전자, 조직 기반 제품 제조에 알맞은 다양한 Cell Therapy System(CTS™) 제품을 구비하고 있습니다. 당사 제품은 연구에서 오염 및 변동성 위험을 최소화하고 규제 검토에 필요한 모든 문서를 제공하므로 실험실 연구에서 임상으로 이행할 때 선택하기에 이상적인 제품입니다.

제품 및 서비스, 주문 정보, 고객 지원에 대한 자세한 정보를 확인하려면 Gibco® CTS™ 브로셔에 접속하십시오.

Discover closed, scalable cell processing and electroporation systems for your GMP iPSC research and manufacturing

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Gibco CTS Rotea Counterflow Centrifugation System

세포 치료제 개발을 위한 유연성 있는 compact한 closed cell processing system

  • Process flexibility – 세포 분리, 세척 및 농축을 위해 사용자가 직접 프로토콜을 제작 및 최적화할 수 있는 소프트웨어가 내장되어 있습니다.
  • High cell recovery and viability – 세포 회수율을 95% 이상 유지하면서 세포 생존율을 유지합니다.
  • Low output volumes – 독점 기술을 사용하여 5 mL 이하로 농축이 가능합니다.
  • Research through commercial manufacturing – 멸균 처리된 closed single-use kit를 이용하며, OPC-UA 인터페이스를 통해 21 CFR 제 11 규정을 준수하는 시스템과 연결할 수 있습니다.

Learn more    Request a demo    Request a quote


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Gibco CTS Xenon Electroporation System

GMP 가이드에 준수한 세포 치료제 개발을 위한 스케일 확장이 가능한 closed electroporation system

  • High speed and large volume – 25분 내 2.5 x 109 T cells/25 mL의 transfection이 가능합니다.
  • Scalable, proven performance and viabilityCTS TrueCut Cas9 Protein을 이용해 최대 90%까지의 gene knockout과 80% cell viability를 확인하였습니다.
  • Process flexibility – 다양한 세포 유형 및 payload에 대한 electroporation 프로토콜을 사용자가 직접 제작 및 최적화할 수 있는 소프트웨어가 내장되어 있으며, 공정 개발부터 상업 생산까지 가능합니다.
  • Efficient nonviral transfection – Xenon MultiShot Electroporation Cartridge는 PVC 또는 C-Flex™ 튜브에 sterile welding을 가능하게 합니다.

Learn more    Request a demo    Request a quote

CTS Dynabeads CD3/CD28

Invitrogen CTS Dynabeads CD3/CD28 for T cell isolation

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

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CTS Dynabeads Treg Xpander

CTS-Dyanbeads

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

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CTS DynaMag Magnet

Invitrogen CTS Dynabeads CD3/CD28 for T cell isolation

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

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CTS LV-MAX Lentiviral Production System

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

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 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)

Flexible packaging format suitable for aseptic integration

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

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CTS™ Immune Cell SR은 임상 샘플의 세포와 조직 배양에서 혈청 대체물로 사용 가능하도록 개발되었습니다. 이 제품은 in vitro 진단용입니다.

  • 인간 혈청과 관련된 공급 및 안전 위험 최소화
  • 다클론 T 세포(CD3/CD28 비드 활성, OKT3 mAb 활성, 바이러스 특이적 및 종양 특이적 T 세포)의 확장 지원
  • 인간 혈청과 유사한 T 세포 표현형(CD4, CD8, CD62L) 지원
  • 유전자 변형 CAR T 세포(렌티바이러스 형질도입) 지원
  • 인간 혈청 적격성 확인과 관련된 비용과 시간 절감
  • 선택한 기본 배지에서 사용하기에 충분한 일반적인 용도

NEW CTS OpTmizer Pro Serum Free Medium (SFM)

Family of Gibco CTS OpTmizer Pro Serum Free Medium

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.

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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

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.

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CTS OpTmizer T Cell Expansion SFM

Gibco CTS OpTmizer T Cell Expansion SFM for human T cell culture

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

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  • 인간 T 림프구 성장 및 확장 도모
  • 완벽한 무혈정, 무이종(xeno-free) 배지
  • 우수한 세포 생활성과 기능
  • 일관성 있는 결과 및 변동성 감소
  • 현재 동봉된 1L 백에 제공되므로 cGMP 환경에서의 작업이 촉진됨

CTS AIM V Medium

Gibco CTS AIM-V without phenol red, without antibiotics for human T cell culture
치료 등급의 무혈청 세포 확장 배지
  • T 세포와 수지상 세포를 증식하고 조작할 수 있도록 최초로 출시된 완전히 정의된 무혈청 제형
  • 인간 ex vivo 조직과 세포 배양 처리 어플리케이션용으로 유일하게 FDA 510(k) 승인을 획득한 상용 T 세포 배지
  • cGMP를 준수하여 제조

더 나은 제품, 지원, 서비스를 고객에게 제공하겠다는 당사의 약속을 이행하려는 노력의 일환으로서 AIM V® Medium가 Gibco® CTS™ AIM V® Medium로 리브랜딩되었습니다. AIM V® Medium, 액체의 사양, 제형, 용도 설명은 그대로 유지됩니다. 주가 지원을 받으려면 당사 기술 지원 팀cts@thermofisher.com으로 이메일을 보내 주십시오.

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NEW CTS TrueCut Cas9 Protein

0.50 mL vial of CTS TrueCut Cas9 Protein shown on left with product packaging shown on right.

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

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PureQuant Assays

CTS PureQuant Assays

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
  • Dynabeads® CD3/CD28 CTS™를 사용한 T 세포의 후속 자극/확장과 확장 프로토콜에 따른 비드 제거 등을 위해 비드 결합 세포를 분리함
  • 밀폐된 멸균 채혈 주머니와 튜브 시스템에서 자기 분리에 매우 적합함
  • 자기 포획된 비드 결합 세포를 폐기하여 원치 않는 세포 유형 제거

더 나은 제품, 지원, 서비스를 고객에게 제공하겠다는 Life Technologies의 약속을 이행하려는 노력의 일환으로서 Dynal ClinExVivo™ MPC® GIBCO® DynaMag™ CTS™ 로 리브랜딩되었습니다.  GIBCO® DynaMag™ CTS™의 용도 진술이 "세포, 유전자, 조직 기반 제품 제조 또는 연구용"으로 새롭게 바뀌었습니다.

CTS DPBS without calcium chloride, without magnesium chloride

Gibco CTS DPBS without calcium chloride, without magnesium chloride in bag and bottle format

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

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  • in vitro 세포의 구조적, 생리적 무결성을 유지해 주는 환경을 조성함
  • 임상 연구 사용에 적합한 고품질 물질 함유
  • 최신 cGMP 및 ISO 인증을 받은 시설에서 제조되기 때문에, 매일 재현 가능한 결과를 얻을 수 있는 최고의 품질과 일관성을 보장함
  • 용도 - 표시
  • 세포, 유전자, 조직 기반 제품의 제조 및 연구용.
    주의: 사람이나 동물에게 직접적으로 사용할 수 없습니다.

CTS GlutaMAX

Gibco CTS GlutaMAX in bag and bottle 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.

  • 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

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QuestionAnswer
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.
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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.
  • 단 하나의 제품으로 T 세포를 ex vivo 방식으로 분리, 활성, 확장할 수 있음
  • 단 9~14일만에 100 – 1,000배 확장된 T 세포 수득
  • in vivo 방식으로 활성된 T 세포와 유사한 특성을 가진 T 세포 회수

더 나은 제품, 지원, 서비스를 고객에게 제공하겠다는 Life Technologies의 약속을 이행하려는 노력의 일환으로서 Dynabeads® ClinExVivo™ CD3⁄CD28이 GIBCO® Dynabeads® CD3/CD28 CTS™로 리브랜딩되었습니다. Dynabeads® CD3/CD28 CTS™의 용도 진술이 “임상 연구용 세포 기반 제품의 비상업적 제조 또는 연구용”으로 새롭게 바뀌었습니다.

  • GIBCO CTS™의 고품질 성장인자와 사이토카인 제품은 T 세포와 수지상 세포 어플리케이션에 적합합니다.
  • 높은 생물학적 활성 - 적은 단백질로도 더 많은 결과 확보
  • 고순도 - 다른 단백질이나 오염물로 인한 간섭 없음
  • ISO 13485 품질 기준에 따라 제조됨
  • DMF는 요청 시 이용 가능

CTS™ 지원

기술 및 규제 지원과 제품 관련 문서

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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.