Cell Therapy Systems (CTS)

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Cell Therapy Systems—a proven choice for clinical cell therapy manufacturing

As you move from basic cell therapy research to the clinic, high-quality GMP-grade cell therapy ancillary materials and proper documentation are essential to getting it right the first time. Cell Therapy Systems (CTS) products provide a proven choice for clinical stem cell therapy and immunotherapy research and manufacturing so you can transition your cell therapy to the clinic with confidence. In addition to providing serum-free, xeno-free and animal origin-free formulations our GMP-grade CTS products have cell and gene therapy specific intended use statements, extensive safety testing and proactive regulatory documentation. We take these measures to provide quality ancillary materials to help minimize risk, ease the burden on your quality systems, and support your regulatory submission—making CTS the superior choice as you transition from the bench to the clinic.

GMP manufacturing

Ancillary materials are manufactured in conformity with cGMP for medical devices, 21 CFR Part 820 and USP <1043>
Our ancillary material manufacturing sites are FDA–registered and ISO 13485– and ISO 9001– certified

Testing and regulatory

Traceability documentation—including Drug Master Files, and/or Regulatory Support Files, and certificates of origin
Extensive safety testing—including sterility, endotoxin, and mycoplasma

Proven use

Used in FDA-approved CAR-T therapies and the first FDA-approved therapeutic cancer vaccine
Used in over 100 clinical trials

Cell therapy applications

Immunotherapy research

Specialized cell therapy systems products to isolate or activate and expand T cells, dendritic cells, or other immune cell types.

Mesenchymal stem cell therapy research

Cell therapy products to help you advance your mesenchymal cell therapies to the clinic. Learn more about tools for characterization, expansion and differentiation.

Induced pluripotent stem cell therapy research

Learn more about our solutions across the Pluripotent Stem Cell workflow from reprogramming to culture.

Neural cell therapy research

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

Cell therapy products for T cell, MSC, PSC, NSC, and HSC

One aspect of successfully transitioning your cell therapy to the clinic involves the careful selection of products from a reliable supplier. Based on your starting cell type (T cells, MSCs, PSCs, NSCs, or HSCs), our interactive product selection tool will help you identify reagents, services, and support that can scale with you from discovery to commercialization.

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Enabling GMP cell therapy development

GMP facilities and manufacturing excellence

Over 30 years of experience with GMP manufacturing enables us to provide high-quality GMP cell therapy ancillary materials. Our ancillary material manufacturing sites are ISO 13485– and ISO 9001–certified, and FDA-registered. And our redundant facilities enables us to supply the highest-quality products to all of our customers globally, uninterrupted.

Quality manufacturing and adherence to regulatory requirements

Gibco CTS products are specifically designed for use in cell therapy applications. The methods and controls used for manufacturing ancillary materials conform to GMP for medical devices, 21 CFR Part 820, and follow USP <1043> and Ph Eur 5.2.12 guidances.

Safety testing

Gibco CTS media and reagents are GMP grade and undergo a high degree QC testing for sterility and presence of any endotoxin, and mycoplasma (on applicable products).

Regulatory documentation

Extensive traceability documentation including FDA Drug Master Files and/or Regulatory Support Files, certificates of analysis, and certificates of origin ease the burden on your quality systems by helping to support your regulatory submission and reduce risk throughout.

Clinical and commercial use

Gibco CTS products have been used in the manufacturing of commercialized cell therapies globally and in over 100 clinical trials. We are committed to enabling our customers’ GMP cell therapy manufacturing by securing commercial use rights.