The first part of the Process Analytical Technology session discusses best practices in the design, implementation, and operation of PAT for actual GMP operations. The design and implementation drive the digital transformation. This includes the IT infrasructure requirements to facilitate the data management under GMP standards, the application of 'classical' PAT based on spectroscopic equipment through to soft sensors i.e., data-driven analytics, and process insights revealed by PAT back to the control strategy as a holistic instrument. The second part of the session is a case study from Takeda's Neuchatel site, tying the strategic vision of digitalization in manufacturing to the real-time benefits of PAT. The Digital Twin Model allows monitoring, investigation and prediction of critical quality attributes (outputs) by varying the process parameters (inputs). Predictive modeling is a key attribute to ensure operational excellence and a robust manufacturing process. This promises to be a great session showing how far PAT techniques and technologies have moved pharmaceutical manufacturing from feedback, reactive approaches to predictive modelling for maximum efficiency and yield.
1530 – 1600: Digital Evolution Strategies in MSAT by Veronika Nindl 1600 – 1700: Application of PAT for Real-World GMP Operations by Dr. Hubertus Rehbaum, Line Lundsberg-Nielsen and Andrew Palm