The application of a Quality by Design (QbD) approach to the development of a freeze-dried pharmaceutical product is a complex science and still a matter of much debate. It certainly requires knowledge of a specific branch of formulation science, an appreciation of equipment limitations, and an understanding of the dynamic interplay between product and process during the various stages of the lyophilization process. This presentation will provide an overview of these issues, highlighting the importance of formulation characterisation, establishing where the main risks lie, and demonstrating how the construction of a design space (or a sequence of linked design spaces) might be approached, while also taking into account the economic constraints of the process. Presented by Dr. Kevin R. Ward, PhD, MRSC R&D Director at Biopharma Technology Ltd.
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