Description:
Pharmaceutical Engineering: A Primer for Advanced Process Development provides a comprehensive, engineering-focused description of pharmaceutical dosage form process development and manufacturing. This volume introduces the most commonly used manufacturing processes for pharmaceutical dosage forms and addresses critical formulation and process parameters that influence drug product process performance and product quality.
This is supplemented with detailed descriptions of engineering models as well as tools that can be used to support their development and verification (such as process analytical technology (PAT)) as well as the appropriate utilization of process and equipment knowledge. Typical scale-up challenges inspired by real industrial examples will be presented as well as a review of the latest correlations, theories and models that can form the basis for science-based scale-ups and transfers.Brief description: 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