Last week, the inspection of the new production plant by the higher federal authority Paul-Ehrlich-Institut (PEI) and the state authority of Saxony took place at the Leipzig site. 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 guarantee the highest safety and quality requirements in the pharmaceutical sector. In addition to ensuring consistent product quality, compliance with it also ensures compliance with the mandatory requirements specified by the health authorities for marketing.
As a result of the successfully completed two-day inspection, neither critical nor serious, but only a few other defects were revealed, which, however, have no influence on the time of the start of production.
At the end of April 2021, the European Medicines Agency (EMA) had the CO. DON AG has been granted approval for its new manufacturing facility in Leipzig.
After an almost one-and-a-half-year intensive implementation and validation phase, all central milestones relevant to the authorities have been reached in line with the time and budget in order to be able to start routine production for Spherox at the Leipzig site in the third quarter of the current financial year and thus supply the European markets.
Tilmann Bur, Ceo of CO. DON AG: "We can be rightly proud of the positive inspection result. We have made great efforts and worked hard to achieve this goal. On behalf of the Board, my thanks go to the entire CO. DON team at both locations, because it was only the joint cross-site performance that made this excellent inspection result possible."
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.
Source: Press release CO. DON AG from 07.06.2021