The CO. DON AG reaches the next milestone on the way to its international business expansion: with the arrival of the first biopsy today, the production of the EU-wide approved drug for clinical use began at the Leipzig site.
After the start of the project in 2017, the completion of the plant construction and subsequent time-consuming validation and qualification work, one of the largest projects in the history of the company could be completed on time and at cost and transferred into routine. Tilmann Bur, CEO of CO. DON AG: “We can rightly be proud to have mastered this mammoth project. The success was only possible thanks to the joint cross-location cooperation of all departments. In addition to the actual structure, related regulatory requirements had to be met in order to comply with the requirements of the European Medicines Agency (EMA) and the national authorities. Our plant, which is now going into production, is one of the largest plants for the production of human cells on an industrial scale. With it, we will continue to ensure the supply of cell therapy products of the highest quality for our users in Germany and Europe as well as other international markets in the future.”
The CO. DON AG develops, produces and distributes the body’s own cell therapies for the minimally invasive repair of cartilage defects. The drug offered is a cell therapy product for the minimally invasive treatment of cartilage damage to the knee joint with only the body’s own cartilage cells. Those of CO. The method offered by DON is currently used in over 200 clinics in Germany and has already been used in over 16,000 patients. In July 2017, CO. DON the EU-wide approval for this drug, in March 2019 the approval for Switzerland. At the Leipzig site, CO. DON one of the largest plants for the production of human cells on an industrial scale for in-house and contract production. The shares of CO. DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Board of directors of the company: Tilmann Bur, Dr. Achim Simons.
For more information, see www.codon.de.
Source: Press release CO. DON AG from 17.08.2021