3DPharmHSI - Personalized medicine

The European Medicines Agency (EMA) has recognized the increasing role of digital tools and data in pharmaceutical regulation, especially for innovative processes like 3D-printing (3DP) that enable customized products such as personalized medicine. Currently applied regulations, designed for large batch manufacturing, often require extensive surplus production for release testing, hampering productivity and delaying patient access. Real-Time Release Testing (RTRT) offers a more efficient alternative, allowing products to be released based on real-time manufacturing data. Despite existing guidelines, widespread adoption of RTRT has been limited in the pharmaceutical industry due to various challenges. Our project aims to address this by developing an RTRT strategy for personalized dosage forms in collaboration with regulators, building upon relevant EMA regulations. To implement the RTRT strategy, we will develop smart data handling, analytics, and automation approaches, introducing disruptive innovation in the pharmaceutical sector. This digital workflow will provide real-time information on product quality for various 3D-printed dosage forms, namely the drug content and drug distribution within the product. The technology to be developed will further enable intuitive automated personalised manufacturing. Ultimately, this project aims to advance data-driven manufacturing, improving the efficiency and sustainability of pharmaceutical production tailored to each patient. Additionally, the technology lays the foundation for extending its application to the production of customised combination products, such as drug-loaded medical implants. In the project, machine learning (ML) models will be assessed and enhanced to streamline data extraction and automate pharmaceutical processes, via intelligent use of data. The regulatory aspect will prioritize building trust with authorities by engaging them in the co-creation of the novel digital technology.