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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.
Categories
Proteins/ Antibodies
Drug product
Process control
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.

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Project Lead

Physical Sciences Inc

Physical Sciences Inc

Participating Organizations

Genentech

Genentech

Massachusetts Life Sciences Center

Massachusetts Life Sciences Center

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)

Purdue University

Purdue University

University of Massachusetts Lowell

University of Massachusetts Lowell

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