Today’s cell and gene therapy manufacturers are transforming lives by making better therapies more accessible. As a result, ensuring the safety and availability of these medicines is paramount.

We recognize that as a supplier into your process we play a critical role in supporting your need for high-quality products, a stable supply chain and robust risk mitigation strategies. Our 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.

Regulatory support

Providing quality for our customers drives everything we do. Gibco CTS products are specifically designed for use in cell, gene, and tissue-engineered applications. Our facilities operate under robust global Quality Management Systems (QMS) certified to ISO 9001 or 13485. Gibco CTS products are designed to meet the US and EU guidelines specific to ancillary materials for CGT (USP 1043*, ISO 20399, EP 5.2.12*).

Our dedicated regulatory and quality teams are focused on providing product support for customer filings. In addition to our comprehensive CTS portfolio of products, we offer regulatory documentation to support your transition from research through to commercialization.

Traceability documentation

We offer extensive traceability documentation including Drug Master Files (DMF) and Regulatory Support Files (RSF), certificates of analysis (COA), and certificates of origin (COO) to ease the burden on your quality systems by helping support your regulatory submission and reduce risk throughout.

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Our biological origin raw material traceability, quality control testing and test method references are detailed on our Certificates of Analysis and Origin. These documents are designed to enable risk assessment of CTS products for use in clinical manufacturing. All CTS products have SDS available. Prior to requesting a DMF or RSF, please contact us to request a COA and COO.

Request form

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Thermo Fisher Scientific has submitted DMFs for many products. Wherever you are in the world, contact our team of cell and gene therapy professionals to cross-reference a DMF or to provide access to RSFs.

Request form

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Change notification

If you wish to be notified of future changes to CTS products, please contact us to request a quality agreement, which includes change notification letters.

Submit request

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Validation guides

We provide validation guides in support of our CTS cell therapy instrumentation. Please submit your request and our quality assurance team will respond in a timely manner. Note: CDAs are not required for this document release.

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Customization capabilities

Do you have a proprietary process that requires special adjustments? We offer full customization options to help meet your unique specifications for any project. No matter your customization needs, our team can offer tailored support to ease your journey. Flexibility is yours in creating your own solution.

  • Add or remove components
  • Change a concentration
  • Switch packaging
  • Select from cGMP or non-GMP
  • Choose QC tests

Learn more about customization capabilities

Educational webinar

Strategic Raw Material Selection for Cell Therapy Commercialization

In the ever-evolving global landscape of cell therapy development, selecting quality raw materials is crucial for achieving clinical and commercial milestones. Download this webinar to hear insights from industry leaders into the key factors influencing raw material selection throughout different phases of development.

Watch now

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Enabling commercial use and supply assurance

We are committed to enabling the commercialization of cell and gene therapies using our Gibco CTS products by customizing formulations/testing, providing continuity of supply, access to relevant regulatory documentation and commercial use rights under mutually committed relationships.

The benefits to the cell therapy developer are multifold:

  • Supply assurance to provide comfort that you will have access to Thermo Fisher Scientific’s products for your drug manufacture at a defined specification and “on time and in full” when required
  • Regulatory support beyond Phase 1 support of our products to help ensure successful regional approvals
  • Commercial use rights extending beyond any applicable Limited Use Label Licenses that are conveyed with the catalog product

For further information regarding how Thermo Fisher Scientific may enable your late-stage cell therapy development and commercialization efforts please contact:

Cell and gene therapy applications

Whether you're developing an induced pluripotent stem cell therapy, specialized immunotherapy, or a gene therapy, our Gibco CTS portfolio offers cell-type and viral vector specific applications that can be leveraged to advance your research to the clinic and beyond.

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T Cell Therapy

Specialized Cell Therapy Systems products to isolate, activate, expand, and genetically modify T cells, dendritic cells, or other immune cell types.

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Natural Killer (NK) Cell Therapy

Explore cell therapy systems products for expansion, processing, and gene editing of human natural killer (hNK) cells for cell therapy development.

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Induced Pluripotent Stem Cell Therapy

Learn more about our solutions across the pluripotent stem cell workflow, from reprogramming to culture.

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Neural Stem Cell (NSC) Therapy

Specialized cell therapy products for stem cell– and tissue-derived neural cell cultures.

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Viral vector systems

We offer complete, optimized systems for scalable, cost-effective adeno-associated virus (AAV) and lentivirus (LV) vector production.

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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