Sartorius CellGenix GmbH
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| GmbH | |
| ISIN | 🆔 |
| Industry | Biotechnology |
| Founded 📆 | 1994 |
| Founder 👔 | Felicia M. Rosenthal, CEO[1] |
| Headquarters 🏙️ | Freiburg, Germany |
Area served 🗺️ | Worldwide |
| Members | |
Number of employees | Approximately 80 |
| 🌐 Website | www |
| 📇 Address | |
| 📞 telephone | |
Sartorius CellGenix GmbH is a global manufacturer of reagents for clinical cell and gene therapy and regenerative medicine, in particular growth factors and serum-free media.[2] The company was founded in 1994 and employs approximately 80 people. The company is headquartered in Freiburg, Germany.
Products and services[edit]
The company's main focus is the development and production of reagents in accordance with GMP (Good Manufacturing Practice) for the ex vivo processing of cells used in research through clinical applications to the commercial production of advanced therapies. These include, in particular, growth factors (cytokines) and serum-free media for the expansion and differentiation of various, human cells: Stem cells (Hematopoietic stem and progenitor cells, MSC, iPC, ESC) dendritic cells, NK cells and T cells. The product range includes bag systems for cell culture and cryopreservation of cells.
History[edit]
The company was founded in 1994 as a spin-off of the University Hospital Freiburg under the name CellGenix GmbH. On behalf of the Freiburg umbilical cord blood bank, the company carried out the GMP preparation and storage of allogeneic umbilical cord blood stem cells for external donations. In 1995, the first GMP manufacturing authorization for blood stem cells was granted in Europe, and by 2010, eight additional GMP manufacturing processes had been approved, including for dendritic cells, chondrocytes and T cells.
Over time, Sartorius CellGenix has undergone a major transformation. In 1996, Metreon Bioproducts GmbH was founded together with Schering AG to specialize in cell processing. The cell therapeutic CartiGro developed by the joint venture was used for autologous chondrocyte transplantation (ACT) to treat accident-related damage to the cartilage of the knee joint with the patient's own cartilage cells.[3] Stryker took over the distribution. For the production of CartiGro, a currently worldwide unique serum-free manufacturing process was used.
A patient-specific, recombinant idiotype vaccine (IdioVax) was developed in collaboration with Freiburg Hospital. The vaccine was used for the treatment of non-Hodgkin's lymphoma and clinical phase II was completed.[4] The vaccine was granted GMP manufacturing authorization in 2001 and EU orphan drug designation in 2004. A GMP manufacturing authorization has been granted for another recombinant tumor vaccine.
Increasingly, Sartorius CellGenix has specialized in the manufacture of reagents for ex vivo processing of cells. In 1997, the first serum-free medium for the cultivation and differentiation of dendritic cells was developed, and in 2002, the first GMP cytokine, interleukin-4, was launched. The product range was expanded to include further cytokines and different serum-free media. From 2000 to 2013, the company had a strategic alliance with American Fluoro Seal Corporation (Afc) based in Gaithersburg, MD (USA), which produced bags for cell culture and cryopreservation, among other applications. Following the acquisition of Afc by Saint-Gobain Performance Plastics in 2013, Sartorius CellGenix continues to act as a distributor in Europe.
As a result of close collaboration with international authorities, in 2010 interleukin-4 became the first cytokine in the world to be produced and marketed in accordance with the new United States Pharmacopeia Specification, Chapter <92>. In both the drafting of the Ph. Eur. General chapter "Raw materials of biological origin for the production of cell-based and gene therapy medicinal products (5.2.12)" (2017) as well as the new ISO standard TS 20399 "Ancillary materials present during the production of cellular therapeutic products" (2018).
In 2021, the life science group Sartorius acquired a majority stake in the company through its subgroup Sartorius Stedim Biotech and renamed it Sartorius CellGenix GmbH.[5]
Structure[edit]
Sartorius CellGenix GmbH is a limited liability company (GmbH). The managing director is Professor Dr. Felicia Rosenthal. The company included the subsidiary Metreon Bioproducts GmbH (headquartered in Freiburg), which performed GMP cell processing. Sartorius CellGenix held shares in Afc Inc. in Gaithersburg, MD (USA) and CellPrep S. A. in Buenos Aires, Argentina. In addition to the company headquarters in Freiburg, Germany, there is a branch office in Portsmouth, NH (USA). The products are sold worldwide directly and through distributors.
References[edit]
- ↑ "Company Page • Sartorius CellGenix". CellGenix. Retrieved 7 January 2022.
- ↑ "CellGenix Completes Facility Expansion to Stay Ahead of the Increasing Demand for GMP Raw Materials". www.b3cnewswire.com. Retrieved 7 January 2022.
- ↑ Foldager, Casper Bindzus; Gomoll, Andreas H.; Lind, Martin; Spector, Myron (April 2012). "Cell Seeding Densities in Autologous Chondrocyte Implantation Techniques for Cartilage Repair". Cartilage. 3 (2): 108–117. doi:10.1177/1947603511435522. ISSN 1947-6035. PMC 4297130. PMID 26069624.
- ↑ "Non-Hodgkin's lymphoma vaccine - CellGenix - AdisInsight". adisinsight.springer.com. Retrieved 7 January 2022.
- ↑ "Sartorius strengthens product portfolio for cell and gene therapies by acquiring a majority stake in CellGenix". Sartorius. Retrieved 7 January 2022.
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