Manufacturing and Bioprocessing – Chemical
2019 PharmSci 360
The development of robust (continuous) drug product manufacturing processes in a timely manner is still challenging due to a lack of mechanistic process understanding, fundamental understanding of influence of raw material attributes, and limited usage of sophisticated process simulation tools. Often, at the early stages of research and development, there is limited amount of raw material available. Experimentally determining the effects of involved process- and formulation parameters and thereafter optimization is labor-intensive, expensive and time-consuming. Therefore, raw material database management and process modeling using multivariate data analysis techniques and mechanistic modeling approaches (i.e., development of predictive platforms and digital twins) can provide a valuable and efficient alternative. This will be demonstrated in this presentation by means of case-studies on continuous manufacturing of drug products. Furthermore, the concept of model-based design of manufacturing technologies will be explained and demonstrated.