A Quality by Digital Design framework for pharmaceuticals and biopharmaceuticals

The pharmaceutical and biopharmaceutical industries are subject to stringent regulatory requirements to ensure quality, safety, and efficacy of the drug products. It is therefore paramount to intelligently design and operate the pharmaceutical and biopharmaceutical processes to deliver quality assurance over the product lifecycle. The introduction of the science and risk-based approach, Quality-by-Design (QbD), has addressed some of these objectives and significantly contributed to the adoption of more effective quality systems. As a result, QbD is increasingly seen as the most reliable regulatory standard in the Pharmaceutical and Biotechnology sectors. However, QbD still requires extensive experimental efforts despite the advantages offered by the traditional model-free design of experiments (DoE) commonly associated with QbD. Most importantly, QbD misses the opportunity to leverage effective model-based methodologies, and more broadly process systems engineering tools, to effectively minimize the experimental efforts, maximise reliability of the design space and achieve robust and fault-free operation. With the emergence of pharma 4.0 and digital transformation, there is an urgent need to develop a digital quality ecosystem which integrates more flexible and effective regulatory standards and advanced digital tools.