Abstract
This chapter provides an overview of design of experiment (DOE) studies of spray-dried vaccines and approaches for scaling the spray-drying process from laboratory to pilot and commercial scale. The chapter aims to present a clearer picture of the field and highlight the factors influencing particle design and vaccine activity. Key aspects of scale-up and the methodology are described along with application examples where scale-up for vaccine powders has been performed. As a result, readers can take away the concept of quality-by-design (QbD) for developing a quality product with predefined goals and understanding the critical process and product parameters based on risk analysis considerations.
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Arpagaus, C. (2023). Design of Experiment Studies and Scale-Up. In: Spray Drying of Vaccines. Springer, Cham. https://doi.org/10.1007/978-3-031-24323-3_5
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