The demanding quality standards required of the manufacturing conditions for human cell transplants led us to develop Integrated Isolator Technology (IIT) alongside our industrial partners, which went into operation at our Teltow site in 1999.
What makes this “clean room within a clean room” so special is that all the equipment required for producing transplants and for quality control is integrated in isolators that meet the highest clean room standards. These isolators are located in an environment that also qualifies as a clean room and are only accessible via airlocks. Pressure differences between the different rooms prevent contamination between one room and another.
Since 2017 the company has been building a second production site in Leipzig in order to satisfy the additional demand that the company’s expansion is expected to generate, now that central EU marketing authorisation has been granted. Once all the work is finished the production site in the Leipzig BioCity district will be one of the largest plants for the industrial-scale production of human cells. Going forward, it will continue to ensure that cell therapy products of the highest quality are supplied to our users in Germany and other European countries.
The principle behind the Integrated Isolator Technology originally developed for Teltow has been refined. Its modular construction means the plant is extremely flexible and can be expanded at any time. Currently it consists of 3 isolators and 144 decentralised, mobile incubators, which have a capacity of 4,500 transplants a year. All resource planning and monitoring of the processes required to produce the cell therapy products is computerised.
With the approval for the site granted by the European Medicines Agency (EMA) in 2021 and the successful completion of the GMP inspection, all key regulatory milestones have been achieved, enabling CO.DON to start routine production for own products in the third quarter of 2021.