Pharmaceutical Engineering: A Primer for Advanced Process Development

Pharmaceutical Engineering: A Primer for Advanced Process Development. Volume 1: Liquid dosage form process design provides a comprehensive engineering-focused description of pharmaceutical dosage form process development and manufacturing. The set is split into two volumes, volume 1 focusing on liquids and volumes 2 on solids. Each volume introduces the most commonly used manufacturing processes for pharmaceutical dosage forms, 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. Pharmaceutical Engineering: A Primer for Advanced Process Development applies engineering in pharmaceutical (drug product) unit operations. Readers benefit from a deep insight into the field written by experts, thereby helping address recent paradigm shifts in the pharmaceutical landscape – i.e. the use of mechanistic process understanding, statistical analyses, AI/predictive analytics, PAT, digital twins, to support risk-based approaches towards process design and scale-up, and building product quality via QbD. For academic scholars in the field, it helps to hone in on the paradigms, progress, challenges, and opportunities being faced in industry. Features engineering principles of pharmaceutical drug product processesIncludes development and scale-up of pharmaceutical drug product processesDefines a robust process via science and engineering-based principles