After the first acceptance inspection by the national authority PEI (Paul Ehrlich Institute) and the Saxony State Directorate, CO.DON AG received the manufacturing license for its newly built production facility at the Leipzig location.
The manufacturing license granted covers both the company's own product, Spherox, and cell production on behalf of third parties. This also confirms the GMP conformity of the Leipzig location. GMP - "Good Manufacturing Practice" is an internationally binding standard to guarantee the highest safety and quality requirements in the pharmaceutical sector.
The granting of the permit was preceded by a three-day intensive inspection of the new facility, combined with an examination of compliance with the regulatory and legal requirements in connection with the manufacture, release and sale of biological medicinal products. The five-person inspection team was very impressed by the technical design of the new incubators, isolators and the loading system. Other focal points were the qualification documents and the quality management system.
During the final meeting, the chief inspector of the GMP audit expressly emphasized the excellent preparation, the smooth process and the high level of commitment shown by the employees of CODON AG.
dr Andreas Eberle, Vice President and Head of Technical Operations: "The construction of a new production facility in compliance with all regulatory requirements and legal requirements in the pharmaceutical sector is always associated with considerable effort and high costs. CO.DON AG was able to complete this extensive task, from the start of the project to the granting of the manufacturing license, while adhering to the planned budget in just over two years with maximum success. This success was made possible above all because we managed to fill important key positions with relevantly experienced specialists during the course of the project and to form a highly motivated team of competent employees. We also worked with strong external partners on the technical implementation. I would like to expressly thank everyone involved at the CO.DON locations in Leipzig, Teltow and Berlin, as well as our external contractors for this extraordinary team effort!"
Tilmann Bur, CEO of CO.DON AG: “Our modern production facility in Leipzig enables the manufacture of human cell products on an industrial scale using the latest technology. CO.DON AG is thus in a position to continue to ensure the market supply of innovative, cell-based medicines in the future with continuously increasing quality requirements in the interests of our patients and customers."
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 with only the body's own cartilage cells. The method offered by CO.DON is currently used in around 200 clinics in Germany and has already been used in over 14.500 patients. In July 2017, CO.DON received from the European MedicinesAgency granted the EU-wide approval for this medicinal product. At the Leipzig location, CO.DON built one of the world's largest and most modern 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.
Source: Press release from CO.DON AG dated November 21.01.2020th, XNUMX