Software and Hardware Tools for Pharmaceutical Lyophilization Scale-up

This project aims to develop and test hardware and software tools that will harmonize pharmaceutical lyophilization process development and scaleup. These tools (models, procedures and sensors) are targeted for application by R&D scientists.

Project status

100% Completed

Solution

Performance Period: 8/1/2018 to 9/30/2020

This project aims to develop and test hardware and software tools that will harmonize pharmaceutical lyophilization process development and scale‐up. These tools (models, procedures and sensors) are targeted for application by research and development scientists and will enable application of rapid and standardized procedures for Quality by Design (QbD)-based process development and process scale‐up. Their application will support both pharmaceutical companies that possess lyophilization expertise and also those companies that have limited experience in freeze drying. In addition to promoting standardized lyophilization process development, comprehensive knowledge of the process design space will enable the creation of higher throughput processes, saving time, money and enabling more efficient production of higher quality products using fewer capital resources.