Monitoring and control is key in bioprocess development. Critical process parameters define the process environment for optimum cell growth and high-titer production. Control loops for temperature, dissolved oxygen (DO), pH, agitation, and level are routinely applied in bioreactor systems. Process Analytical Technology (PAT) provides deeper insights into the metabolic state of the culture and facilitates automation.
Through the seamless integration of autosamplers and analyzers such as biomass monitors, cell counters, mass spectrometers, and HPLC, process engineers advance their development and work in line with Quality-by-Design (QbD) guidelines. Design of experiments (DoE) and multivariate analysis (MVA) are statistical tools to streamline experiments, which we discuss here in more detail.