Path to Smart Manufacturing and Intelligent Development within Industry 4.0 - Building an Integrated Sensing Strategy
Over the years there have been many frames of reference on the use of process analytical technology (PAT) in the commercial manufacturing space including monitoring, closed loop control, quality control/real time release, advanced process control, quality by design, Industry 4.0, etc. With each evolution of framing, the context we view process sensing and analysis of manufacturing processes is trending towards expanded scope and context from unit operation to production train, plant level, and up through manufacturing network, supply chain and value chain to customer. Similarly in the Development space, the frame of reference on the use of PAT continues to evolve as various capabilities become standard aspects of pharmaceutical and biopharmaceutical process technology stacks enabling the use of digital twins, modeling, and workflow automation which aim to drive more efficient and reliable development, technical transfer, and lifecycle management practices. In this talk we will present how we at Biogen are integrating PAT as part of our Digital Evolution strategy on a pathway towards realization of Smart Manufacturing and Intelligent Development.