Teltow / Leipzig, 17 August 2021 - CO.DON AG achieves the next milestone on the path of its international business expansion: with the arrival of the first biopsy today, routine production of the EU-approved pharmaceutical officially started at the Leipzig site.
After the project start in 2017, the completion of the plant construction and subsequent time-consuming validation and qualification phase, one of the largest projects in the company's history was completed on time and on budget and transferred into routine. Tilmann Bur, Executive Board of CO.DON AG: "We can be proud of having managed this extensive project. The success of the project is the result of cross-site collaboration between all departments. In addition to actually building the plant, related regulatory requirements had to be met in order to comply with the requirements of the European Medicines Agency (EMA) and the national authorities. The production site is one of the largest plants for the industrial-scale production of human cells. It will continue to ensure that cell therapy products of the highest quality are supplied to our clients in Germany and other European and international countries."
CO.DON AG develops, produces and distributes autologous cell therapies for the minimally invasive repair of cartilage defects. The product being marketed is a cell therapy product for the minimally invasive treatment of cartilage damage in the knee joint that uses only the patient's own cartilage cells ("autologous chondrocytes"). CO.DON's method is currently used in over 200 clinics in Germany and more than 16,000 patients have already been treated. In July 2017 CO.DON AG received central EU marketing authorisation for this product, followed by the marketing authorization for Switzerland in March 2019. At the Leipzig site, CO.DON has built one of the largest facilities for the production of human cells on an industrial scale for in-house and contract manufacturing. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Executive Board: Tilmann Bur, Dr Achim Simons.
Further information is available from www.codon.de.
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