CO.DON AG has reached 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 the subsequent time-consuming validation and qualification work, one of the largest projects in the history of the company could be completed on time and on budget and transferred to routine. Tilmann Bur, CEO of CO.DON AG: “We can be justifiably proud of having mastered this mammoth project. The success was only possible thanks to the joint cross-site cooperation of all departments. In addition to the actual construction, 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 facility, which is now going into production, is one of the largest facilities for the production of human cells on an industrial scale. With it, we 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.”
CO.DON AG develops, produces and sells endogenous 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 in the knee joint using only the body's own cartilage cells. The method offered by CO.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 received EU-wide approval for this drug, and in March 2019 approval for Switzerland. At the Leipzig site, CO.DON built 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, please visit www.codon.de.
Source: Press release CO.DON AG from August 17.08.2021th, XNUMX
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