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

Industry Need

Freeze drying can be a complex operation requiring the development of a complex

process design, and largely because of this complexity and the lack of adequate

process analytical technology, most commercial freeze drying processes are suboptimal,

thereby wasting time and/or placing product quality at risk.

Solution

The project team will develop and

test new automated tools for the development and scale-up of pharmaceutical lyophilization

processes. These tools will provide a standardized approach for process development and

scale-up.

Outputs/Deliverables

Aseptic pilot scale lyophilizer R&D facility at UMass Lowell


User friendly lyophilization primary drying process development and scale up

model that accounts for process heterogeneity


Simplified CFD based computational model to predict the mass flow rate

lyophilizer equipment capability curve.

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Project Lead

Physical Sciences Inc

Physical Sciences Inc

Participating Organizations

Genentech, Inc.

Genentech, Inc.

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