Mabion S.A. is the first company in the world to cultivate recombinant CHO cell on an industrial scale, for which it uses Kuhner 2500l, a bioreactor based on disposable technology. The bioreactor used in research was an orbital shaker prototype with the capacity of 2500 litres. A number of improvements were introduced to the device’s software, controls, construction and operational elements, as well as the maintenance of realised processes. The changes introduced to the prototype allowed to transform this machine, which was originally based on the 200 l Kuhner model, into a fully professional system which allows to conduct advanced projects in the field of biopharmacy in accordance with the principles of Good Manufacturing Practice (GMP). So far orbital shaking bioreactors have been used by only on a small scale, mostly by pharmaceutical companies in R&D pilot processes. They had never been used in the GMP environment in a large scale production. Mabion S.A. achieved innovations in the following fields:
- Implementation of the world’s first ever bioreactor process based on sterile and disposable materials on an industrial scale, i.e. “breaking the scale barrier” using disposables – without any contact between the cell culture and the device;
- obtaining the first recombinant therapeutic protein in a bioreactor based on the disposable technology on an industrial scale;
- obtaining the first recombinant therapeutic antibody fully compliant with its GMP specification criteria in a bioreactor based on the disposable technology on an industrial scale.
From its very beginning, Mabion S.A. has focused on innovations, especially in the field of technology, as they translate into success and a long-term presence on the market. Choosing adequate methods was possible thanks to thorough understanding of the process examined from the cell clone level. Mabion has developed the technology on its own – from a pilot scale to development of the industrial scale application. Breakthroughs made by the company’s experts proved that it is possible to use disposable technology for cell culture cultivation on an industrial scale. Thanks to the conducted research, the Company has significantly increased its monoclonal antibodies production scale – from 200 to 2500 litres – and has detected no differences in the qualitative attributes of the so-obtained proteins.