Towards Autonomous Operation by Advanced Process Control—Process Analytical Technology for Continuous Biologics Antibody Manufacturing

Continuous manufacturing opens up new operation windows with improved product quality in contrast to documented lot deviations batch or fed-batch operations. A more sophisticated process control strategy is needed adjust parameters and keep constant during long-term In the present study, applicability of a combination spectroscopic methods was evaluated enable Advanced Process Control (APC) continuous by Analytical Technology (PAT). upstream processing (USP) aqueous two-phase extraction (ATPE), Raman-, Fourier-transformed infrared (FTIR), fluorescence- ultraviolet/visible- (UV/Vis) spectroscopy have been successfully applied for titer purity prediction. Raman most versatile robust method USP, ATPE, precipitation therefore recommended as primary PAT. later stages, UV/Vis fluorescence able overcome difficulties prediction induced overlapping side component spectra. Based on developed predictions, dynamic unit operations demonstrated simulation studies. PAT development workflow holistic proposed.