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 USP<1043> and Ph Eur 5.2.12
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
Used in FDA-approved CAR-T therapies and the first FDA-approved therapeutic cancer vaccine
Used in over 200 clinical trials
Gibco CTS Rotea Counterflow Centrifugation System
A compact, flexible closed cell processing system, designed to streamline and expedite your cell therapy development, that enables:
Process flexibility—user-programmable software enables you to create and optimize a broad range of protocols for cell separation, washing, and concentration
High cell recovery and viability—gentle processing enables >95% cell recovery while maintaining cell viability
Low output volumes—proprietary technology can deliver as little as 5 mL of concentrate
Research through commercial manufacturing—the closed single-use kit enables sterile processing, and an OPC-UA interface enables connectivity to a 21 CFR Part 11-compliant system
Cell therapy applications
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.
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 strategically located facilities help enable us to supply the highest-quality products to all of our customers globally, uninterrupted.
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.
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.
Clinical and commercial use
Gibco CTS products have been used in the manufacturing of commercialized cell therapies globally and in over 200 clinical trials. We are committed to enabling our customers’ GMP cell therapy manufacturing by securing commercial use rights.
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).
Knowledgeable regulatory support team with experienced cell therapy professionals and regional technical support.
Cell Therapy Systems products
CTS Essential 8 Medium
CTS Immune Cell Serum Replacement
CTS AIM V Medium (-) antibiotics (-) phenol red
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