Cell Therapy Systems (CTS)

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 products 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

  • Manufactured in conformity with cGMP for medical devices, 21 CFR Part 820 and USP <1043>
  • FDA–registered manufacturing site with an ISO 13485–certified quality
 
 

Testing and regulatory

  • Traceability documentation—including Drug Master Files, and/or Regulatory Support Files outside USA, and certificates of origin
  • Extensive safety testing—including sterility, endotoxin, adventitious agent, 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
 

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 products. Our manufacturing sites are ISO 13485–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 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, adventitious agent, and mycoplasma (on applicable products).

Regulatory documentation

Extensive traceability documentation including FDA Drug Master Files and Regulatory Support Files outside USA, 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.

Professional support

Knowledgeable regulatory support team with experienced cell therapy professionals and regional technical support.

A Gibco CTS Mini-Documentary Series

Cell Therapy Systems products

Resources

Cell Therapy Learning Center
This collection of resources will help you gain a better understanding of cell therapy research

Cell Therapy Brochure
Learn about our solutions to help you achieve your cell therapy goals from research to commercialization

CTS Brochure
Learn more about our Cell Therapy Systems product offerings with our CTS brochure

Selection guide
Get help choosing cell therapy products for your cell type

Support

Need technical support?
Contact our experienced technical and regulatory support team for CTS products

Request more information
Learn about our solutions to help you achieve your cell therapy goals from research to commercialization

Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.