Process Analytical Technology for Precipitation Process Integration into Biologics Manufacturing towards Autonomous Operation—mAb Case Study

The integration of real time release testing into an advanced process control (APC) concept in combination with digital twins accelerates the towards autonomous operation. In order to implement this, on one hand, measurement technology is required that capable measuring relevant data online, and other a suitable model must be available calculate new parameters from this data, which are then used for control. Therefore, feasibility online techniques including Raman-spectroscopy, attenuated total reflection Fourier transformed infrared spectroscopy (ATR-FTIR), diode array detector (DAD) fluorescence demonstrated within framework analytical (PAT) initiative. best result achieved by Raman, reliably detected mAb concentration (R2 0.93) purity 0.85) time, followed DAD. Furthermore, DAD Raman has been investigated, provides promising extension due orthogonal methods higher robustness. led prediction R2 0.90 ± 3.9% 0.72 4.9%. These run simulation studies show twin APC concept.