Product development issues for PEGylated proteins

摘要: Covalent attachment of poly(ethylene) glycol (PEG) groups to proteins, a process commonly called PEGylation, is often used improve the performance protein in vivo. To date, at least eight such PEGylated peptide and conjugates have been approved as therapeutic agents many more undergone clinical trials. This review examines PEGylation from perspective developing commercially viable drug product. The first section focuses on obtaining pure well-characterized substance. latter discusses formulation manufacturing issues, with an emphasis analytical methodology that provides most detailed description purity stability proteins.