Monoclonal antibodies (mAb) represent the main group of biologics, which are the fastest growing part in pharmaceutical industry. Production of biologics is very expensive due to its complexity and demanding manufacturing processes. For that reason they remain unaffordable to many patients. The main focus of the pharmaceutical industry is therefore the development of new, cost effective and more efficient preparation processes. Chromatography is most commonly used technicque for purification and isolation of biologics. Nowadays, batch chromatography still has important role but especially for large scale, continuous chromatography shows better economical results and productivity.
The main purpose of master thesis is development of more efficient and cost effective first chromatography step for purification and isolation of monoclonal antibodies, which is chromatography on protein A resins. In preliminary studies we evaluated different protein A resins and optimized existing length of sequence, where we focused on efficient impurity removal. We developed continuous chromatography step on 3 columns using BioSMB system, where we determined the most optimal parameters. Additional experiments on two additional monoclonal antibodies were done, to show robustness of the developed process. Since trends in industry are going towards a more connected processes, we also connected bioprocess part with protein A chromatography step as first process step of protein purification and isolation. The last part of this thesis was economical evaluation between batch and continuous chromatography, where we confirmed benefits of newly developed process.
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