Deploying Modeling & Simulation to Enable Advanced Process Monitoring & Control

Several enabling technologies change the way we do pharmaceutical development: automation and digitalization, advanced analytical methods, modeling, and simulation. But especially the latter are not silver bullets, and it is important to have a closer look at why and when one might use them.

In this presentation, we focus on the real-time applications of modeling and simulation in the context of process monitoring & control: how to leverage the underlying technologies to better visualize current process data, improve process control decisions, and anticipate future process trajectories.

We discuss factors and prerequisites supporting a successful and sustainable implementation, from the “digital maturity” of the processes over the necessary technical building blocks (like robotics and high-throughput experimentation) to aspects of people mindset and change management and what it means for an organization to embrace these new ways of working.

Presented by Johannes Scheiblauer, Associate Scientific Fellow for Digital CMC at Takeda

Followed by Sean Bermingham, head of formulated products at Siemens

Sean joined Siemens Process Systems Engineering in 2000 and has been Head of SPSE’s Formulated Products business unit since 2009. Before this role, he was SPSE’s Global Head of Consulting. In his current role, he is responsible for strategic business development, software product development, and service delivery for the pharma, food, consumer goods, mining, specialty, and agrochemical industries. Sean is a leading figure in the development and adoption of mechanistic model-based tools for increasing R&D efficiency and managing risk in areas ranging from clinical trials to tech transfer and operations. He is one of the founders of the Systems-based Pharmaceutics Alliance with Bayer, GSK, Lilly, Pfizer, Roche, and Sanofi and was the lead for the £20.4 million ADDoPT “Digital Design” Project with partners including AZ, BMS, GSK, and Pfizer. Sean is a chemical engineer with an MSc in Chemical Engineering, a PhD in crystalization from Delft University of Technology, and an Executive MBA from Imperial College London.

Sponsored by Siemens gPROMS and gPROMS Formulated Products

About Siemens gPROMS

Siemens provides a family of technology-leading gPROMS modeling environments for digital process design, engineering, and operations. These deploy deep process knowledge to accelerate process and product innovation, reduce the need for experimentation and pilots and design better, safer processes that lock in value over the asset lifetime, creating value at every step.

About Siemens gPROMS Formulated Products

Built on the Siemens gPROMS® advanced process modelling platform, gPROMS FormulatedProducts helps organizations bring high quality drugs to patients faster through the rapid configuration, calibration, and deployment of science-based, data-calibrated digital process twins. The tool contains a suite of mechanistic and hybrid models of unit operations such as bioreactors, chromatography, membrane filtration, crystallization, spray drying, and granulation, combined with in vitro and in vivo product performance models. Since 2013, the offering has been pioneering the emerging science of systems-based pharmaceutics with Bayer, Eli Lilly, GSK, Pfizer, Roche, and Sanofi.”