Author Archives: Thomas Budde Hansen

Model-Assisted Process Development for Preparative Chromatography Applications

Process modeling is a core technology in biopharmaceutical production that ensures faster, safer processing and process development. Developing a model involves quite some work, so it is important to use the model efficiently. We describe an industry example of how a mechanistic model is best used under process development and how it increases process understanding and performance. Present State of Process Development Biopharmaceutical process development relies heavily on experimentation and previous experience expressed as “rules of thumb” and empirical correlations.…