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CellGenix GmbH – Cell therapy and all that is needed

Researchers and medical doctors aim to cure diseases such as cancer using cell therapies. However, university laboratories and small companies frequently lack the capacity to grow stem and immune cells under the required quality conditions. CellGenix was spun out of the Freiburg University Medical Centre around 17 years ago with the aim of cultivating and commercialising therapeutic cell material in compliance with high safety and quality standards. The Freiburg-based company has since become a leading manufacturer and supplier of cartilage cells and umbilical cord stem cells. It also supplies clients with high-quality reagents for their work with cells.

Mesenchymal stem cells (here seen under a light microscope) are one of the many products marketed by Freiburg-based CellGenix GmbH. © CellGenix GmbH

Stem cells are said to be able to do almost anything. What they definitely can do, is to go through numerous cell division cycles while maintaining an undifferentiated state and to give rise to any mature cell type. Researchers around the world have been trying for many decades to establish culture conditions that enable stem cells to differentiate into myocardial, nerve or blood cells. These efforts might at some point in the future help regenerate brain, blood or heart tissue in patients suffering from cancer, for example. “17 years ago, researchers and medical doctors of the Department of Haematology and Oncology at the Freiburg University Medical Centre considered the possibility of establishing a company focused on cell therapy,” said CellGenix GmbH’s CEO Prof. Dr. Felicia Rosenthal. “Back then, transplantation was done using cells from the patients’ bone marrow and blood, and the idea was to culture the patients’ stem cells under GMP conditions.”

Expanding the product portfolio step by step

CellGenix GmbH works in compliance with the highest quality and safety standards, which requires, amongst other things, the use of a GMP clean room for the production of sterile products. © CellGenix GmbH

GMP stands for “good manufacturing practice” and refers to the general principles that must be observed during the manufacture of cell materials or molecules in laboratories, including procedures to exclude contaminations and the recording of all manufacturing steps so that the complete history of a batch can be traced in a comprehensible and accessible form.

CellGenix GmbH started off by commercialising haematopoietic stem cells and the company established the first GMP laboratory for the production of haematopoietic stem cells in 1995 at the Freiburg University Medical Centre. CellGenix was the first company in Europe to be granted a licence for the production of haematopoietic stem cells under GMP conditions.  The company was granted licences for the production of dendritic cells in 1998  and chondrocytes in 1999. In 1996, the Freiburg-based company joined forces with Berlin-based Schering AG to establish Metreon Bioproducts GmbH that focuses on cell-based cancer therapy and is in charge of the umbilical cord blood bank at the Freiburg University Medical Centre. In 2001, CellGenix relocated to new laboratory premises covering a surface area of 2000 sqm. CellGenix now has a staff of fifty.

“We have since gone one step further,” said Rosenthal going on to add “as a GMP manufacturer of cells, we know that our clients who work in clinical settings frequently lack the necessary equipment to handle cells according to the quality standards required for material used in clinical trials.” This is why CellGenix has gradually expanded its product portfolio of “ex vivo therapeutics”. The company has developed serum-free media for the cultivation of its own cells and now sells these media to research institutions around the world, including institutions that carry out clinical studies to assess the efficacy of certain cell therapy forms, as well as to international pharmaceutical and biotechnology companies. Serum-free media are required for the cultivation of cells which must not come into contact with nor take up animal protein. This guarantees that patients who are treated with proteins produced by cells kept in serum-free media do not come into contact with proteins that would alert their immune system and lead to the rejection of the implanted cell materials. The use of serum-free media also simplifies the quality and safety inspections by regulatory authorities to which all pharmaceutical producers are subject.

Ex vivo therapy – what is it all about?

CellGenix GmbH’s product portfolio already includes serum-free media for the cultivation of dendritic cells, haematopoietic stem cells and chondrocytes. At present, the company is working on the development of a serum that is suitable for the cultivation of mesenchymal stem cells derived from solid body tissue. It also plans to reinforce the development of serum-free media that enable the cultivation of induced pluripotent stem cells (iPS), which have become increasingly important in research. In addition to media, CellGenix also sells recombinant proteins that are of great importance for ex vivo cell processing. Examples of such proteins are growth factors that are indispensable for the growth and differentiation of stem cells into specialised cell types. “Pharmaceutical companies and clinical research institutions can purchase from us specifically defined, customised growth factor cocktails that are produced under GMP conditions,” said Rosenthal. “We are constantly reviewing the literature and exploring the market, which enables us to adapt the cocktails to the protocols a particular laboratory follows to culture and differentiate certain cell types.”

CellGenix GmbH also supplies the hardware that is required in the field of ex vivo therapy, for example bioprocessing containers and freezing bags. © CellGenix GmbH

CellGenix GmbH also sells the hardware needed for cell therapy projects. For example, it offers so-called closed kit systems, which are hermetically sealed cell culture containers that help exclude contaminations. These Teflon containers have excellent gas transfer rates and are transparent, which enables the easy investigation of cell cultures under the microscope. The company’s cryopreservation bags (KyroSure Freezing Bags) make it possible to cryropreserve cell materials without problems. “We have been working in the field of cell therapy ever since the company was established, and we have now expanded our know-how to the GMP-conformant production of material that is required for work with cells. We can now offer an all-inclusive service for the cell therapy market.” CellGenix GmbH’s position as an international leader in the production and supply of products and services for the cell therapy market is highlighted by the fact that the United States Pharmacopeia (USP), an independent health authority in the USA, has asked the company to formulate quality standards for the field of ex vivo therapeutics. This request most certainly has a lot to do with the company’s 17 years of experience and its high quality standards.

Further information:
Prof. Dr. med. Felicia M. Rosenthal
CEO
CellGenix GmbH
Am Flughafen 16
79108 Freiburg
Tel.: +49 761 / 88889 – 100
Fax: +49 761 / 88889 – 880
E-mail: Rosenthal(at)cellgenix.com

Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/cellgenix-gmbh-cell-therapy-and-all-that-is-needed