Comecer, Italian designer and producer of isolation equipment and systems, has agreed a deal with German biopharmaceutical company Co.Don for the supply of modular isolator and cell culture incubation systems in an aseptic environment for a new cleanroom production site being built in Leipzig. The value of the contract is approximately €10 million.
Co.Don carries out research, development and marketing of autologous cell therapies for the repair of cartilage defects. It designs therapeutic products that only use the patient’s own cells and blood, that are additive-free and the procedure is minimally invasive. To date, over 11,000 patients have been treated in 200 clinics in Germany. In July 2017, Co.Don received marketing authorisation for the advanced therapy medicinal product, Spherox, from European Medicines Agency (EMA).
Ralf Jakobs, CEO of Co.Don said: “We are delighted to have such an experienced partner as Comecer, with its many years of specialist expertise. Together we will perform this challenging task. Co.Don is entering a new dimension: once all the work is finished, the production site will be one of the world’s largest and most modern plants for the industrial-scale production of human cells. It will enable us to ensure the supply of the highest quality cell therapy products to our customers in Germany and Europe going forward.”
This order is seen by Comecer as important as the equipment made in Castel Bolognese will be used inside one of Europe's main biopharmaceutical plants.
Alessia Zanelli, CEO of Comecer Group said: “We are honoured to be part of this great project in what is considered the future of medicine. The fact that our patented technology has been selected by Co.Don makes us proud and confirms the considerable commitment undertaken by our company in this rapidly developing sector.”
A period of 10 to 12 months has been set for the modification and installation of the new machinery at the Leipzig site. This will be followed by an intensive validation and qualification process in order to meet the high regulatory standards for pharmaceutical products.