Lypholization

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Application of first principles primary drying model to lyophilization process design and transfer: case studies from the industry

Application of first principles primary drying model to lyophilization process design and transfer: case studies from the industry

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 Excel–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. Written by members of the BioPhorum’s Lyophilization Workstream, this paper published in the Journal of Pharmaceutical Sciences 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.

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