Lyophilization
Transform freeze-dried product development with our approach, focusing on cake structure to predict and optimize lyo cycle, ensuring stability and efficiency.
Issue
The development of freeze-dried products involves an intricate formulation and process space, where the balance of product stability and an efficient, scalable process must be navigated. In addition to cycle development, a rapid and consistent reconstitution time must be reached. Finally, manufacturing must be proven robust in producing good cake quality. Our mission is to transform lyo cycle development by using the cake structure as a surrogate to predict sublimation and reconstitution mass transport phenomena.
Common Challenges
- Lengthy cycle development.
- Variable and/or slow reconstitution times.
- Resources spent troubleshooting incomplete reconstitution, micro-collapse, and poor cake quality.
- Cake quality issues overlooked by visual inspection.
Related Applications
Solution
Our innovative workflow is built to quantify the structures formed by ice and its sublimation during drying stages. Non-destructive, quantitative analysis of porosity and cake walls enables an advanced understanding of mass transport phenomena for freeze-drying and reconstitution. Using a digital twin of the real world cake structure enables in silico prediction of sublimation resistance and reconstitution properties. From these analyses, we often support the development of correlative process and formulation models. Our solution has helped speed up formulation selection, reduce guess work in cycle optimization, boost confidence in cake quality, and assure batch quality during scale up. This workflow has also been applied to spray-freeze dried particles.
Our Approach
- Prediction of sublimation resistance to identify critical process parameters.
- Connection of structures and performance with reconstitution prediction.
- Root cause discovery for defects.
- Quality assurance for scale up with quantitative cake uniformity.
Formulations
Studied
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