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It usually takes 5-10 years and 1-3 billion USD to reach market approval for drug products. This creates a huge bottleneck when it comes to providing affordable drugs and preventing drug shortages. Besides conducting clinical trials to understand the effectiveness and safety of a new product, a process needs to be developed and approved by regulatory agencies that consistently delivers high product quality. This process development including process characterization (PCS) takes 2-4 years and needs several hundred experiments adding up to a multi-million-dollar undertaking!
In this article we would like to introduce a self-learning digital twin that enables the reduction of required experiments in PCS by more than 50% and hence also time to market.