digiM Webinar: Shortening Lyophilization Cycle Development

Microstructure CQAs

The microstructures of freeze-dried cakes and particles are critical to the performance and quality of the final product. From porosity to wall thickness, there is a wide array of parameters to understand during cycle process development and formulation. 3D non-invasive inspection with high-resolution X-ray CT and AI analysis plays a fundamental role in these steps. In this webinar, the use of these techniques to quantify important CQAs will be demonstrated. The application of image-based simulation towards predicting transport properties such as sublimation and reconstitution will also be reviewed. This novel microstructural analysis can be a critical pathway towards rapid and easier process design in lyophilization development.

Key Learning Objectives:

  • What kind of cake attributes can we quantify with non-invasive analysis?
  • How can these CQAs accelerate process and formulation selection?
  • How can modeling be used to understand cake transport properties and performance?

Transform Your Program with Microstructure Science

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