Implementation of a fully integrated manufacturing platform for biosimilar mAb based on continuous chromatography, in combination with single-use disposable technology for all unit operations of DSP on pilot/small production scale together with incorporation of advanced analytical tools.
- Utilization of flocculants and Tangential Flow Filtration (TFF) or ATF for primary separation.
- Integration of continuous chromatography in the capture step and development of novel disposable equipment for larger scale. Development and evaluation of non-chromatographic capture step alternatives (precipitation reagents).
- Comparative evaluation of single-use disposable equipment and technology over hard-piped equipment of the exemplary process (intermediate/polishing and UF/DF step), including the testing of new mAb flow-through template and membrane adsorbers.
- Development of advanced analytical tools for in-line monitoring of quality attributes