Freeze-drying Process Development for Protein Pharmaceuticals

نویسنده

  • BYEONG S. CHANG
چکیده

This chapter provides an overview of the impact of protein formulation variables on different stages of the protein freeze-drying process and offers guidance for selection of critical process parameters during protein freeze-drying cycle development, optimization, and scale-up. There is particular focus on practical considerations including large-scale process development, scale-up challenges, and issues with less conventional freezedrying delivery systems, such as dual-chamber syringes.

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تاریخ انتشار 2012