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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