SFAK20002U Cancelled Advanced Manufacturing of Pharmaceuticals

The course will introduce the critical tools needed for future professionals working in drug development and manufacturing of pharmaceuticals. The main goal is to provide students with knowledge required for designing robust medicinal product using Quality by Design (QbD) principles. The course will start by introducing the unit operations used in manufacturing of pharmaceuticals. This part covers primary manufacturing of both small molecules (synthesis and crystallization) as well as biologics (fermentation and related separation technologies), followed by introduction of secondary manufacturing steps (granulation, tableting and coating), as well as spray/freeze drying technologies for biologics. Special focus will be on introducing enabling manufacturing solutions for nanomedicine. Theory and practice will be introduced hand in hand with lectures and excursions to local industry including examples from both small molecule and biologics. Next phase involves the introduction of central Quality by Design tools - Design of Experiments (DoE) and chemometrics, as well as physical modelling of system behavior. Students will be introduced to different levels of modelling used in designing robust manufacturing processes – starting from modelling molecular interactions explaining the behaviour of systems with pharmaceutical interest, and proceeding to modelling of process performance based on engineering principles. Specific examples of process analytical technologies (PAT) will be discussed with a special focus on analytical tools applicable for the analysis of moving matter. The last part of the course provides deeper insight into the general structure of pharmaceutical quality systems and risk management approaches. Principles of the plant design of pharmaceutical manufacturing sites will be introduced. For project work, students will work in small groups of 4 students around given formulation/processing example. Project work will be presented during project presentation.