Company Page • Sartorius CellGenix

OUR FOCUS

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.

OUR HISTORY

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 2003 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 & 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. RosenthalManaging Director

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 LeistlerVice President Production

Bernd Leistler joined CellGenix in 2003. As Vice President Production, Bernd is responsible for all GMP cytokine products for further manufacturing use, as well as process development for protein production. This includes lyophilized formulation in pharmaceutical glass vials, liquid formulation in syringes and other formats. 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 corporate service unit for recombinant and conventional human autoantigens and allergens.

At CellGenix he first took responsibility for production of various protein vaccines. Having acted as a Qualified Person under supervision of the competent authorities, he now uses his knowledge and experience to ensure that cytokine production is in line with the GMP guidelines.

Dr. Till PuschmannVice President R&D and Business Development

As Vice President R&D and Business Development, Till is responsible for the development of CellGenix’ product portfolio and broadening of the pipeline. He also acts as Senior Project Manager steering and supporting interdepartmental projects. Till holds a Diploma degree in biochemistry from the Free University Berlin, Germany, and received his Ph.D. in neurosciences from the University of Melbourne, Australia.

Till spent five years in Gothenburg, Sweden as a postdoctoral researcher at the University and was founder and CEO of an innovative biotech company focused on neural 3D cell culture systems. He has authored more than ten research publications (some in high-impact journals) and holds several patents. Before joining CellGenix in Freiburg in 2018 he served as management consultant for the pharma industry in the U.S. where he gained deeper insights in large pharma’s processes and structures.

Daniel SpatzVice President Sales, Marketing & Logistics

Daniel Spatz joined CellGenix in 2021. As Vice President Sales, Marketing & Logistics Daniel is responsible for the entire global sales and marketing organization. He is also in charge of the logistics and customer service organization for our headquarters (CellGenix GmbH, Germany). He holds a degree in business administration as Bachelor of Arts from DHBW Mannheim, Germany.
Daniel started his professional career in 1996 as Account Manager tissue culture products at Becton Dickinson GmbH in Germany, a leading multinational medical and life science manufacturer. In the following years he took over several leading positions in sales and marketing for the BD Biosciences business unit Central Europe and was part of the leadership team. Before joining CellGenix Daniel was responsible as CBO for the global sales and marketing organization at PromoCell GmbH, a premier manufacturer for primary cells and media.

SCIENTIFIC ADVISORS

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. 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.

Dr. med. Joachim-Friedrich Kapp

Dr. med. Joachim-Friedrich Kapp served in the pharmaceutical industry for thirty-five years. As president of the Global Business Unit Therapeutics he was a member of the executive committee (Portfolio Board) at Schering, in which the Board of Directors, the three regional heads and the three business unit heads determined the company’s strategy. Dr. Kapp is a member of the CellGenix Supervisory Board, since 2019 its Vice-Chairman; he serves on several other boards of biotech companies in Germany and the USA.

Prof. em. Dr. Dr. h.c. mult. Roland Mertelsmann

Roland is a hematologist, oncologist and professor emeritus at the University Medical Center, Department of Oncology, Hematology, and stem cell transplantation in Freiburg, Germany. He started his career as a medical student at the Universities of Göttingen and Hamburg, Germany and King’s College School of Medicine London, UK. After his graduation at the University of Hamburg, he moved to Memorial Sloan-Kettering Cancer New York, NY, USA (MSKCC, 1976 – 1986). His group was successful in isolating the blood stimulating growth factors G-SCF for granulocytes and natural Interleukin 2 for T cells which were patented by MSKCC. In 1985, he became professor and head of the Department for Hematology and Oncology at the University of Mainz, Germany, and since 1989 at the University of Freiburg, Germany, continuing his clinical work and research in malignant hematology and stem cell transplantation.

COOPERATIONS

Ori Biotech and Sartorius CellGenix collaborate in order to promote innovation within closed-system, cell and gene therapy manufacturing. Our collaboration with Ori Biotech will offer our joint customers an innovative closed-system manufacturing platform including the necessary CellGenix® high-quality raw materials. More about Ori Biotech

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

Sartorius 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.

SPONSORING

We are proud to be the first annual sponsor of the Advanced therapy medicinal products Manufacturing Community. The amc is working closely with the ATMP manufacturing community in the UK to develop best practice in cell therapy manufacturing. Learn more about this community: atmpmanufacture.org/

Sartorius CellGenix is industry community supporter of the International Society for Cellular Therapy. ISCT is a global society of clinicians, regulators, technologist, and industry partners with a shared vision to translate cellular therapy into safe and effective therapies to improve patients’ lives. Learn more about ISCT: International Society for Cell & Gene Therapy (isctglobal.org)

Sartorius CellGenix is a member of Alliance for Regenerative Medicine. ARM is the preeminent global advocate for regenerative and advanced therapies. ARM fosters research, development, investment and commercialization of transformational treatments and cures for patients worldwide. Learn more about ARM: alliancerm.org/

Sartorius CellGenix is a proud member of UK BioIndustrie Association. www.bioindustrie.org

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

Sartorius 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.

SPONSORING

We are proud to be the first annual sponsor of the Advanced therapy medicinal products Manufacturing Community. The amc is working closely with the ATMP manufacturing community in the UK to develop best practice in cell therapy manufacturing. Learn more about this community: atmpmanufacture.org/

Sartorius CellGenix is industry community supporter of ISCT (International Society for Cellular Therapy). Read more about ISCT

Sartorius CellGenix is a member of ARM (Alliance for Regenerative Medicine). Read more more about ARM