Sartorius CellGenix is a leading global supplier of high quality raw and ancillary materials for the expanding market of cell and gene therapy and regenerative medicine.
We develop, manufacture and market human cytokines, growth factors, and other recombinant cell culture components in preclinical and GMP quality as well as proprietary serum-free media for further manufacturing of ATMPs. Our products are used by academia and industry partners in clinical trials and commercial manufacturing throughout the world. As an ATMP developer and manufacturer we gained in-depth cell culture knowledge and superior regulatory expertise. With this unique background we understand the high requirements our customers face during product development and the regulatory approval process.
Sartorius CellGenix is headquartered in Freiburg, Germany and operates a subsidiary near Boston in Portsmouth, USA.
Sartorius CellGenix has more than two and a half decades of in-house expertise in GMP manufacturing and development of products (for dendritic cells, HSC, cord blood cells and chondrocytes) in the field of cell and gene therapy and regenerative medicine. The company was founded in 1994 as a spin-off of Freiburg University Medical Center and was the first European company to obtain a GMP manufacturing authorization for cell processing in 1995.
Sartorius CellGenix’ current Quality Management (QM) system was established for manufacturing of recombinant protein investigational products (patient specific idiotype vaccines and recombinant tumor vaccines) in compliance with GMP under manufacturing authorization from German regulatory authorities. The QM system has been adapted for manufacturing of recombinant raw materials and is ISO certified since 2012 (currently DIN EN ISO 9001:2015).
Being active in the cell and gene therapy space for many years, Sartorius CellGenix has always taken active interest in supporting the advancement of the regulatory framework in this evolving environment. We have filed a first FDA DMF for a cytokine as ancillary reagent in 2002 and have co-authored chapter <92> with the USP in 2010.
To meet the increasing demand for GMP quality raw materials for ATMP manufacturing we are now investing in capacity expansion and are building additional R&D laboratory, production and warehouse space. The upgrade also introduces state-of-the-art automated large scale capacities for recombinant protein products in the existing GMP facilities.
Our mission is to enable and accelerate safe and efficient transition of cell, gene and tissue engineered products from preclinical to post-approval clinical applications for the benefit of patients worldwide. We foster this by providing premium ancillary products, reagents, tools and expert regulatory support to our academic and industry partners worldwide.
We aim to be a key provider in the fight against disease, the preferred supplier of raw materials and tools and trusted partner for large scale manufacturing in the cell and gene therapy as well as the regenerative medicine space.