Digitization in bioprocessing: The role of soft sensors in monitoring and control of downstream processing for production of biotherapeutic products

Owing to the advancement in the technologies, the vision of smart manufacturing is not implausible. Development of sophisticated measuring tools, modelling approaches, improved computational efficiency, wireless technology and emphasis on automation and digitalization has promoted soft sensor implementation in bioprocessing . With multiple driving forces including decrease in operational cost, reliable operation, ease in calibration, increased long term stability etc., soft sensor has become a central process analytical tool for accessing and maintaining real time critical quality attributes . Fundamentally, soft sensor is an indirect measurement method combining process data and a mathematical model to estimate a target quantity. The model input is primarily composed of hardware signals from inline process sensors, analytical devices, actuators, and the instruments. This article offers an overview of soft sensing techniques in downstream bioprocessing for production of biotherapeutic products. Novel possibilities that its implementation presents towards real time measurement, monitoring, modelling and control (M 3 C) during commercial manufacturing have been highlighted along with the technology challenges and potential solutions from a data scientist perspective.