An in-line process monitoring control system and method for in-situ, real time monitoring and control of nutrient and carbon source feeding in bioreactors is described. The Ranger responds to the overall metabolic environment of the process under observation and is highly sensitive to any molecular level perturbation in the process media, such as occurs when a biological process is fed nutrients and carbon sources. An automatic, closed loop adaptive feeding protocol that responds to these real time changes in nutrients then maintains proscribed optimum nutrient concentrations. Faster process development cycles, time to clinic, and the promise of better product quality and titer are typical outcomes. The system can actively and independently manage multiple feeds to further optimize bioreactor optimization. Additonal applications of this technology in media preparation and in downstream processes will be discussed. The system is applicable to all scales of operation and modalities from process development to commercial production in fed batch, perfusion, and continuous operation. It is compatible with SUBs. This technology is applicable in microbial, fungal, and mammalian cultures.

Advanced process optimization - a novel, in-situ real time adaptive control system to accelerate and optimize biologics process development and manufacturing

255th National Meeting (2018)

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