Last week, the new production plant at the Leipzig site was inspected by the higher federal authority Paul-Ehrlich-Institut (PEI) and the state authority of Saxony. The content of the inspection was the implementation of the GMP guidelines imposed by the health authorities. GMP - "Good Manufacturing Practice" is an internationally binding standard to ensure the highest safety and quality requirements in the pharmaceutical sector. In addition to ensuring consistent product quality, compliance with this also ensures that the binding requirements specified by the health authorities for marketing are met.
The result of the successfully completed two-day inspection showed neither critical nor serious, but only a few other defects, which have no influence on the start of production.
At the end of April 2021, the European Medicines Agency (EMA) granted CO.DON AG approval for its new manufacturing facility in Leipzig.
After an intensive implementation and validation phase of almost one and a half years, all central milestones relevant to the authorities have been reached on time and on budget, so that routine production for Spherox can begin at the Leipzig location in the third quarter of the current financial year and thus be able to supply the European markets.
Tilmann Bur, CEO of CO.DON AG: “We can rightly be proud of the positive inspection result. We have made great efforts and worked hard to achieve this goal. On behalf of the Management Board, I would like to thank the entire CO.DON team at both locations, because it was only the joint performance across locations that made this excellent inspection result possible."
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.
Source: Press release CO.DON AG from June 07.06.2021th, XNUMX