A complete process for production of a biopharmaceutical consists of a great number of distinct unit operations, for example, cell culture, filtration, and chromatography. Linking these different steps together to a fully continuous process can be a challenging task, and studies in the area of continuous processes typically deals with single unit operations, such as perfusion cell culture or continuous chromatography. Examples where two or more unit operations are connected and integrated are therefore of great interest for understanding the technical solutions as well as the approach for overall control.
This application note demonstrates how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semicontinuous process. In brief, the mAb process consists of perfusion cell culture, continuous capture chromatography, viral inactivation (VI), post VI filtration, batch polishing chromatography, and a final pH adjustment step.