CellGenix

High Quality GMP Reagents for Cell and Gene Therapy Manufacturing

CellGenix is an internationally leading supplier of high quality reagents and tools in the expanding market of cell and gene therapy, and regenerative medicine.

As the first company to obtain a GMP manufacturing authorization for cell processing in Europe, CellGenix has more than 20 years of expertise in the development and GMP manufacturing of cell and gene therapy products.

As trusted supplier, CellGenix offers a comprehensive product portfolio to ensure a seamless transition from research to commercialization. Included in our product portfolio are cytokines, serum-free media and closed cell culture systems. Our products combine a maximum of quality and safety with excellent performance due to state-of-the-art production, stringent in-house control and comprehensive documentation. All these factors help to simplify qualification and validation for your market authorization.

CellGenix operates a state-of-the-art GMP facility for production of recombinant proteins and cell processing in Freiburg, Germany. A subsidiary is located near Boston in Portsmouth, NH/USA.

Regulatory Excellence

CellGenix GMP products are based on three major quality standards:

  • Safety – Safe and qualified raw materials in compliance with our animal-derived component-free and serum-free policy.
  • GMP Compliance – Manufacturing and quality control following all applicable cGMP guidelines to provide documented evidence of purity, potency, consistency and stability.
  • Qualified Products – GMP products are manufactured, tested, released and distributed under an ISO 9001:2008 certified Quality Management System and allow for the safe use in accordance with USP Chapter <1043> and Ph.Eur. General Chapter 5.2.12. GMP cytokines are tested and released according to United States Pharmacopeia Chapter <92> as applicable. We offer expert regulatory and technical support as well as FDA Drug Master Files for most of our products. Customized solutions can be provided to meet special compliance needs.

Safe │ GMP Compliant │Qualified

For more information, visit www.cellgenix.com

CellGenix GmbH, Am Flughafen 16, 79108 Freiburg, Germany

+49 761 888 89-0