Protein and Peptide Formulation Development
作者： Satoshi Ohtake , Wei Wang
DOI: 10.1002/9780470571224.PSE510
关键词:
摘要: Proteins/peptides are generally much more sensitive to process- or storage-induced degradations than small synthetic molecules. Therefore, significant efforts needed formulate these protein/peptide drug candidates into viable commercial products.This chapter reviews the degradation processes in proteins/peptides, describes factors affecting stability, and discusses strategies successful development manufacturing of products. Keywords: protein formulation development; fill-finish processes; protein instability; aggregation; macromoelcular crowding; tangential flow filtration (TFF); lyophilization
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