Transforming Pharmaceutical Development through Continuous Processing and Application of Predictive Sciences

Responding to the challenge of bringing life-changing treatments and medicines with the utmost quality standards to the patients worldwide, the pharmaceutical industry is undergoing a transformational change to reduce the development timelines. Two major transformations which are driving these changes are the transition from batch to continuous manufacturing technology and the digitalisation of product and process design activities. The digital twin of continuous process plays an important role from early to late stages of process development. It allows extensive analysis of the process while minimising experimentation at scale and progress using less material. The process knowledge generated from digital twin and other models are getting integrated with the experimental data in the relevant sections of regulatory filing dossier to further strengthen the overall scientific and technical content.