Application of First Principles Primary Drying Model to Lyophilization Process Design and Transfer: Case Studies From the Industry

Abstract

Lyophilization modeling is well documented in academic circles but has not yet been widely adopted by pharmaceutical manufacturing companies. To facilitate wider adoption and implementation, an accessible ExcelTM-based tool is provided, presenting several fresh examples as a practical introduction to the process of modeling the primary drying phase. Case studies are presented of the tool's application during process development and scale up which highlight business benefits that have been realized by using the model. The authors and contributors are members of the BioPhorum's Lyophilization Workstream and represent several pharmaceutical companies. The current manuscript is intended to serve as a pathway to not only share the collective knowledge on the topic but also accelerate its adoption in the industry.

Keywords: Freeze-drying; Lyophilization; Mathematical model(s); Mechanistic modeling; Quality by design (QBD); Simulation(s).