As you scale your cell and gene therapies beyond research, products designed to enable clinical and commercial manufacturing are essential to your success.

The Gibco CTS portfolio of cell and gene therapy products are GMP manufactured, safety tested and backed by regulatory documentation to support your transition from discovery through clinical and commercial manufacturing. Through our CTS solutions, we are committed to helping customers streamline therapeutic development, minimize risk, and ease the burden on their quality systems.

Safety testing with accompanying traceability documentation

  • Extensive qualification and testing of critical raw materials
  • Final product testing (e.g., mycoplasma, endotoxin, sterility)
  • Types of traceability documentation: COO, COA, SDS  

Dedicated regulatory and quality teams provide product support for customer filings

  • Types of specialized documentation include: DMF, RSF, validation, regulatory agency letters
  • Products used in over 200 clinical trials and commercialized therapies
  • Global CGT regulatory affairs teams with regional expertise

GMP manufactured products designed for CGT manufacturing

  • Designed to meet latest guidance for ancillary materials for CGT (USP 1043*, ISO 20399, EP 5.2.12.*)
  • Products manufactured under global quality standards (QMS ISO 9001 or 13485)
  • 30 years of GMP-compliant manufacturing
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Cell Therapy Systems support

Providing quality for our customers drives everything we do. In addition to our comprehensive CTS portfolio of products, we offer regulatory documentation to support your transition from research through to commercialization. Experienced cell and gene therapy professionals, technical support teams, and highly specialized scientific teams are available to answer your questions, provide detailed product and protocol consultation, as well as customization services.

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Going green: Enabling sustainability in our CTS products

leaf icon Sustainable solutions

We are committed to delivering products that serve the research needs of our customers, while striving to develop them in a way that minimizes our use of natural resources and our impact on the environment.

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leaf icon Responsibly packaged

Packaging must protect the product inside—but that doesn’t have to mean sacrificing sustainability. GlutaMAX-I Media Supplement ships at ambient temperature. By “going ambient” for the GlutaMAX Supplement, we help divert an annual total of nearly 2,000 kg (2,700 ft3) of EPS from landfills and incinerators, and reduce the total carbon footprint by over 100 tons annually. 

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

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新! Gibco™ CTS™ Rotea™逆流离心系统-用于细胞治疗生产的封闭式细胞处理系统

多功能Gibco™ CTS™ Rotea™逆流离心系统是一种高度通用的系统，具有出色的灵活性。系统内置用户可编程的软件、大量细胞处理应用程序，以及用于从科学研究到商业化生产的实用程序。

  • 低输出体积—通过专利技术可产出低至5 mL的浓缩物
  • 处理灵活—用户可编程的软件可创建和优化广泛的细胞分离、洗涤和浓缩方案
  • 优异的细胞回收率和活性—温和的流化床支持低剪切处理，可回收> 95%的细胞，同时还能保持细胞活性
  • 实现科研到商业化生产的转化—封闭式一次性使用试剂盒可确保无菌化处理，OPC-UA接口可连接至符合21 CFR第11部分的系统

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Gibco CTS Xenon 电转染系统

Gibco CTS Xenon 电转染系统

一款用于细胞治疗的的封闭式、可放大规模的、符合GMP生产的的系统

  • 处理量大且快速：处理量为1–25mL，25分钟内能够转染多达2.5x109 个T细胞；
  • 性能可靠，可保持高细胞活力：使用CTS TrueCut Cas9蛋白进行基因编辑，高达90%的基因敲除效率和80%的细胞活力；
  • 工艺灵活性高：仪器配备了用户可编程系统，允许用户在细胞治疗的工艺开发到商业化生产的所有阶段，根据各种细胞类型和目标递送物创建并优化电转染方案；
  • 非病毒性物理转染：可用于递送DNA、RNA和蛋白质；
  • 封闭式系统处理工艺：MultiShot(MS)耗材可以无菌焊接至PVC管或C-Flex管。

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For Research Use or Manufacturing of Cell, Gene, or Tissue- Based Products. CAUTION: Not intended for direct administration into humans or animals.

* CTS products are designed to meet USP <1043>, ancillary material responsibilities for cell, gene, and tissue-engineered products, under a robust Quality Management System certified to ISO 9001 or 13485. All aspects of USP <1043> are the responsibility of the end user to assess. We are dedicated to supporting our customers clinical translation. For regulatory documentation support please contact us.

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