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.
- 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
- Traceability documentation—including Drug Master Files, and/or Regulatory Support Files, and certificates of origin
- Extensive safety testing—including sterility, endotoxin, and mycoplasma
Cell therapy applications
Specialized cell therapy systems products to isolate or activate and expand T cells, dendritic cells, or other immune cell types.
Cell therapy products to help you advance your mesenchymal cell therapies to the clinic. Learn more about tools for characterization, expansion and differentiation.
Learn more about our solutions across the Pluripotent Stem Cell workflow from reprogramming to culture.
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.
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.
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).
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.
Knowledgeable regulatory support team with experienced cell therapy professionals and regional technical support.
A Gibco CTS Mini-Documentary Series
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
Learn more about our Cell Therapy Systems product offerings with our CTS brochure
Get help choosing cell therapy products for your cell type
NEW One Cell Bio product handbook
Review our integrated system solutions and powerful tools to accelerate research
Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.