Pharmaceutical Engineering: A Primer for Advanced Process Development

René Holm received his pharmaceutical training at the Royal Danish School of Pharmacy, now the school of pharmacy at University of Copenhagen, Denmark, in 1998 and his PhD in biopharmaceutics from the same institution in 2002. Dr. Holm joined Lundbeck in 2001 and changed to Janssen in 2016. Dr. Holm has worked within pharmaceutical development and the associated process development, developability in drug discovery, physical chemistry and material science covering both small and large molecules. As of 2021 Dr. Holm have been a full professor in Pharmaceutical physical chemistry at the university of Southern Denmark. Dr. Holm is (co-) author of more than 230 original articles in peer-reviewed journals and patents in the field of biopharmaceutics, preformulation, formulation and physical pharmacy and is an honorary professor in physical chemistry at the Department of Science and Environment, University of Roskilde, Denmark Noor Al-Rifai is a senior scientist at The Janssen Pharmaceutical Companies of Johnson & Johnson within small molecule drug product development – process engineering. Dr Al-Rifai graduated from the University of Birmingham with an MEng in chemical engineering with business management (2009) and from UCL with a PhD in micro-reaction engineering (2016). Dr Al-Rifai’s professional experience spans pharmaceutical and consumer goods product and process development – Merck Sharp & Dohme (2009-2010), Procter & Gamble (2016-2018) and currently Janssen/Johnson & Johnson (2018-Present). At Janssen, Dr Al-Rifai is delivering on engineering strategies to optimise and accelerate product, process development and technology transfer. Dr Al-Rifai is a Chartered Engineer by the Engineering Council/Institution of Chemical Engineers (CEng) and Fellow of the Higher Education Academy (FHEA), the latter gained in her role as Teaching Fellow at UCL Chemical Engineering (2014-2016). Ashish Kumar is Assistant Professor for Pharmaceutical Engineering at Ghent University, Belgium. With his mathematical modeling and simulation background, Dr. Kumar is leading a team involved in the research and development of detailed mechanistic and data-driven frameworks to predict key quality attributes for pharmaceutical processes. His current areas of interest are in understanding constitutive mechanisms that influence the drug processing during manufacturing and hence its performance in the patient to streamline the development processes, which can support the risk-based decision-making paradigms and get products faster to market. Dr. Kumar also holds the Principal Scientist – Process Engineering position in the Drug product development division of Janssen Pharmaceutica, Belgium, where he is actively involved in developing continuous manufacturing processes for solid dosage forms.

• Section 1: The Basics1. Introduction2. General introduction to the field of drug product design and development, including current challenges and recent trends.3. Regulatory considerations for pharmaceutical process development4. A description of ICH Q8 (R2) in the relevant context, including process requirements, QbD options and experimental/computational approaches, as well as a description of pharmaceutical process validation5. Engineering fundamentals6. The basic components needed to understand and build an engineering approach to a pharmaceutical drug product process, including and not limited to: material and energy balances, heat and mass transfer, dimensional analysis, flow of fluids and powders, scale-up approaches and workflows. This will be an introductory chapter and will be covered in more detail in section 2.7. In process analysis8. A description of some of the general analytical options that can be used for experimental characterization of drug product processes and the link to subsequent chapters, including the PAT regulatory status. The analytical principles behind common measurements across the different unit operations will be presented hereSection 2: Unit Operations9. Mixing processes10. Conventional dispersed systems – suspensions and emulsions11. Advanced drug delivery systems - microparticles, liposomes, LNP and similar platforms12. Lyophilization13. Capsule filling – liquid14. Engineering of sterilization processes