Comprehensive insights into process analytical technology for pharmaceutical freeze-drying

Process Analytical Technology for Pharmaceutical Freeze-Drying provides a comprehensive and forward-looking overview of monitoring and control strategies for one of the pharmaceutical industry’s most technically demanding manufacturing processes. Combining scientific fundamentals with industrial case studies, the book examines both established and emerging technologies used to improve process understanding, optimise cycle design, and ensure consistent product quality.

Coverage includes the measurement and interpretation of critical process variables such as temperature and pressure, wireless sensing technologies, pressure-rise methods (MTM, PRA, DPE), tunable diode laser absorption spectroscopy (TDLAS), near-infrared (NIR) and Raman spectroscopy, infrared thermal imaging, and advanced data analysis approaches. Dedicated chapters also explore through-vial impedance spectroscopy (TVIS) as a non-invasive technology for real-time monitoring of product temperature, ice mass, sublimation behaviour, and phase transitions.

The book further discusses innovations in continuous and alternative freeze-drying platforms, controlled nucleation technologies, multiplexed PAT systems, and the growing role of artificial intelligence and model-based control strategies in pharmaceutical manufacturing.

Sample topics explored in Process Analytical Technology for Pharmaceutical Freeze-Drying include:

• Temperature and pressure measurement technologies and their application to freeze-drying process monitoring and control
• Wireless sensing approaches for real-time monitoring of pharmaceutical freeze-drying
• Pressure-rise and sublimation-flow methods for determination of product temperature, sublimation rate, and heat and mass transfer parameters
• Spectroscopic, impedance-based, and thermal imaging techniques for advanced process analysis and optimisation
• Emerging freeze-drying technologies, continuous manufacturing approaches, and AI-enabled process control strategies

Process Analytical Technology for Pharmaceutical Freeze-Drying is an essential resource for scientists and engineers involved in pharmaceutical freeze-drying, PAT implementation, formulation development, process optimisation, and manufacturing scale-up.

Geoff Smith is Professor of Pharmaceutical Process Analytical Technology in the Leicester School of Pharmacy at De Montfort University, UK. He is responsible for the development of through-vial impedance spectroscopy (TVIS) as a PAT tool.

Davide Fissore is Full Professor at Politecnico di Torino, Italy. He is a member of the International Society for Lyophilization and Freeze-Drying and member of the Editorial Advisory Board of the Journal of Pharmaceutical Sciences.