Company 2017-09-18T16:39:53+00:00
OUR FOCUS

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.

CellGenix is headquartered in Freiburg, Germany and operates a subsidiary near Boston in Portsmouth, USA.

OUR HISTORY

CellGenix has more than two 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.

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 9001:2008 certified since 2012.

Being active in the cell and gene therapy space for many years, 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 expanstion 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 & VISION

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.

MANAGEMENT TEAM
Prof. Dr. Felicia M. Rosenthal
Prof. Dr. Felicia M. RosenthalChief Executive Officer

As one of the co-founders and first General Manager Felicia Rosenthal has led CellGenix since 1994. She studied medicine at the University of Mainz and the University College of London, completed a post-doctoral fellowship at Memorial Sloan Kettering Cancer Center, New York, and received her habilitation for work with retroviral gene transfer in cancer immunotherapy. Felicia obtained her medical specialisation in laboratory medicine.

Felicia also holds an executive MBA degree from the WHU Koblenz and J.L. Kellogg Graduate School of Management at the Northwestern University, Chicago. From 2004 until 2013 she served on the Management Board of BIO Deutschland, the German Biotechnology Industry Organisation and from 2014 until 2017 on the Board of BIOValley Deutschland, the European Life Sciences Cluster in Southwest of Germany.

Dr. Bernd Leistler
Dr. Bernd LeistlerVice President Development & Production

Bernd Leistler joined CellGenix in 2003. As Vice President Development & Production at CellGenix, Bernd is responsible for all products including serum-free media and cytokines for ex vivo cell processing. Bernd has a long track record as protein specialist. Following his degree in chemistry he joined the Basel Biocenter for his dissertation on the structure, function, folding and assembly of oligomeric proteins. He continued these studies as a postgraduate researcher in Cambridge, UK.

His professional career started in 1993 at a leading manufacturer of diagnostic autoantibody immunoassays which later became part of Pharmacia Diagnostics. There he managed the Biotechnology Department and developed it as a coporate service unit for recombinant and conventional human autoantigens and allergens.

Frank Hecht
Frank HechtVice President Marketing & Sales

Frank Hecht joined CellGenix in 2014. As Vice President Marketing & Sales Frank is responsible for the management of the global customer-oriented activities and the strategic marketing positioning of the company. He in addition manages the Logistics Department. Frank holds a Master’s Degree in Biology from the University of Osnabrück, Germany. During his 15+ years in several sales and marketing functions he gained significant insights into the international life science industry.

Before joining CellGenix Frank managed the North American business for Eppendorf and set up the local Eppendorf offices in Seoul, South Korea.

SUPERVISORY BOARD

CHAIRMAN

Dr. Georg F. Drischel
Attorney at Law, Freiburg

 

MEMBERS

Prof. Dr. Roland Mertelsmann
former Head of Department of Hematology / Oncology University Medical Center, Freiburg

Dr. habil. Joachim-Friedrich Kapp
former President GBU Specialized Therapeutics Schering AG, Berlin

Jochen Stotmeister
General Manager, Stotmeister Beteiligungs GmbH

Christophe Vérolet
Head of Internal Audit STO Group

SCIENTIFIC ADVISORY BOARD
Prof. Dr. Cliona Rooney
Prof. Dr. Cliona Rooney

Center for Cell & Gene Therapy, Baylor College of Medicine, USA

Cliona Rooney serves in the Department of Pediatrics, Molecular Virology and Microbiology and Immunology and is the Director of the Translational Research Laboratories at the Center for Cell and Gene Therapy at Baylor College of Medicine.

Cliona brings over 20 years of expertise in the field of T cell immunotherapy for virus-associated diseases and cancer. She was instrumental in the development of T-cell therapies virus-specific T-cells in the stem cell transplant setting and has further developed and refined antigen-specific T-cells for the treatment of cancer. Her current interests are in gene modifications and other strategies to render T-cells effective within an immunosuppressive microenvironment.

Dr. Anthony Davies
Dr. Anthony Davies

Dark Horse Consulting Inc., USA

After training as a biochemist, chemical engineer and molecular biologist, Anthony Davies has worked in the cell and gene therapy field for some 20 years. Over this period he has held positions of increasing responsibility at companies including Onyx Pharmaceuticals, Geron Corporation and Capricor.

He is now president of Dark Horse Consulting (DHC), a boutique practice focussed on CMC and product development issues in monoclonal antibody, cell and gene therapies. DHC is based in California and has a European office in London – its clients range from academic institutions, through small and mid-sized companies to global pharmaceutical companies.

Dr. Mitchell H. Finer
Dr. Mitchell H. Finer

MPM Capital, USA

Mitch Finer has over 30 years of experience in the areas of regenerative medicine, cancer immunotherapy and cell and gene therapy, where he helped to advance products from conception through phase III clinical programs. 

Mitch founded Oncorus and currently serves as CEO and CSO. In 2015 he joined MPM Capital as Managing Director and is a member of the board of directors of MPM portfolio company Semma Therapeutics. Prior to MPM, Mitch served as CSO of bluebird bio, where he was responsible for strategic elaboration of bluebird’s gene-modified adult hematopoietic stem cell therapy business and led the strategic development and partnering of CAR-T and genome engineering programs.

COOPERATIONS

We have entered into a cooperative network, 3D-Bio-Net, for the development of a platform for 3D bioprinting of tissues and organs. The goal is to develop an open, generic platform for the digital bioprinting of tissues and to test these in two promising applications: drug development and bioprinting of organs for transplantation.  The complete production process will be tested and demonstrated on a dedicated 3D bioprinter with CAD and control software, a line-up of validated and partially even certified biomaterials, and a collection of process instructions. Read more

CellGenix is the official distributor of Saint-Gobain Life Sciences. We distribute the bioprocessing containers manufactured by Saint-Gobain within Europe. The portfolio includes different types of cell culture bags, cryopreservation bags and corresponding accessories.

COOPERATIONS

We have entered into a cooperative network, 3D-Bio-Net, for the development of a platform for 3D bioprinting of tissues and organs. The goal is to develop an open, generic platform for the digital bioprinting of tissues and to test these in two promising applications: drug development and bioprinting of organs for transplantation.  The complete production process will be tested and demonstrated on a dedicated 3D bioprinter with CAD and control software, a line-up of validated and partially even certified biomaterials, and a collection of process instructions. Read more

CellGenix is the official distributor of Saint-Gobain Life Sciences. We distribute the bioprocessing containers manufactured by Saint-Gobain within Europe. The portfolio includes different types of cell culture bags, cryopreservation bags and corresponding accessories.

CAREERS

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