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Overview
Welcome to BioNetwork’s third lyophilization course. In this 20-minute course, we’ll explore the critical aspects of formulation development and learn how to design and optimize freeze-drying cycles. We'll also cover advanced topics such as the application of Quality by Design (QbD) principles and the evaluation of new technologies.
Objectives
Upon completion of this course, you'll be able to:
- Explain the critical factors in developing a lyophilized product formulation, such as pre-formulation studies, selection of appropriate excipients, and compatibility studies.
- Outline the steps involved in developing a freeze-drying cycle, including determining critical temperatures, optimizing process parameters, and scaling the lyophilization process from lab to production scale.
- Describe new technologies in lyophilization, such as ice fog for controlled nucleation and liquid nitrogen refrigeration.