Thermo Fisher Scientific, LIMS & Laboratory Software

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.

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GMP manufacturing

  • 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

Proven use

  • Used in FDA-approved CAR-T therapies and the first FDA-approved therapeutic cancer vaccine
  • Used in over 200 clinical trials