A novel process design for automated quality analysis in an integrated biopharmaceutical platform

This contribution describes a novel process design consisting of the implementation of a high performance liquid chromatography (HPLC) system into an existing integrated biopharmaceutical purification platform in order to extend the possibilities of analysis. This setup is controlled by a custom-made set of software tools, namely the combination of Orbit along with a C# based program called Satellite, which is used to link the HPLC system to Orbit. By using this process design, automated analysis of the continuous process flow is made possible, generating full wavelength spectra, and automated pool quality analysis. These spectra contain at least an order of magnitude more data compared to a standard chromatogram, which can be utilized for further analysis, while the pool quality analyses can be used for making decisions regarding how to proceed with a particular pool. The results of the study show the successful implementation of automated analytic tools to the purification process, which also indicates that the process carries promise as a generalizable platform for Orbit-controlled designs for different analysis purposes