Performance Period: 12/15/2020 to 2/28/2023
This project will develop and test a Process Analytical Technology (PAT) Enabled Freeze-Dryer, incorporating automated process control based on critical product parameters. The PAT Enabled Freeze-Dryer will use real-time measurements to automatically control lyophilization processes based on key product parameters (KPPs), such as the critical product temperature and target product temperature during primary drying. The team will combine lyophilization process development models and enhanced control algorithms, and allow the user to define the PAT instrumentation available on the dryer, thereby providing broad applicability within the pharmaceutical industry.
The PAT Enabled Freeze-Dryer will use real-time measurements to automatically control lyophilization processes based on key product parameters (KPPs), such as the critical product temperature and target product temperature during primary drying.
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Physical Sciences Inc
Genentech, Inc.
Merck Sharp & Dohme LLC
National Institute for Pharmaceutical Technology and Education, Inc (NIPTE)
Pfizer, Inc.
University of Massachusetts Lowell
