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Automated Process Control of Pharmaceutical Lyophilization: PAT Enabled Freeze-Dryer

Develop and test a PAT enabled Freeze-Dryer, with automated process control based on critical product parameters.
Categories
Drug substance
Process control
Project status
100% Completed

Solution

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.

Outcomes and Impacts

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.

Updates, Related Publications, and Deliverables

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Project Lead

Physical Sciences Inc

Physical Sciences Inc

Participating Organizations

Genentech

Genentech

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

National Institute for Pharmaceutical Technology and Education, Inc (NIPTE)

National Institute for Pharmaceutical Technology and Education, Inc (NIPTE)

Pfizer, Inc.

Pfizer, Inc.

SP Scientific
University of Massachusetts Lowell

University of Massachusetts Lowell

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