March 9, Cambridge, Massachusetts. New week, new continent. After our trip to Asia, GoSilico was traveling the US this week.
First stop: IFPAC conference from March 4th until 6th in North Bethesda, Maryland. The IFPAC conference series aims at leading the way in advanced manufacturing science through innovation, emerging technologies, and control. Besides industry and academia, also a large number of FDA staff joined the event to learn and discuss the latest trends in the pharmaceutical, biotech, chemical, and related industries. Modeling and model-based pharmaceutical development and manufacturing were thereby one of the key topics. So a lot of talks focused on modeling and related topics, such as model maintenance, validation and life cycle management – of course, also Thiemo Huuk’s talk, who presented GoSilico in Maryland.
In his talk on “A QbD-guided, Model-Based Approach to Chromatography Process Development and Characterization”, he showed GoSilico’s recent approaches towards the assessment of the model’s predictive capabilities used in QbD-based process development. Such a model assessment relies on an investigation of probability densities of the uncertain parameters. Thiemo showed, that mechanistic models can be used to extrapolate to process conditions far beyond the actual calibration range. However, the quality assessment proved outstanding predictive capabilities and model results were perfectly in line with the experimental validation. Following, we moved on to Massachusetts and visited a couple of companies in Cambridge, the heart of the biopharma innovation and enjoyed some really exciting and fruitful meetings.
The title pic shows a late night ChromX session in Maryland.