Journal
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY
Volume 16, Issue 5, Pages 423-440Publisher
TAYLOR & FRANCIS LTD
DOI: 10.3109/10837450.2010.513990
Keywords
Protein stability; pegylation; development; chemical modification
Categories
Funding
- National Institutes of Health [R01 HL078944-01]
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Covalent attachment of poly(ethylene) glycol (PEG) groups to proteins, a process commonly called PEGylation, is often used to improve the performance of a protein in vivo. To date, at least eight such PEGylated peptide and protein conjugates have been approved as therapeutic agents and many more have undergone clinical trials. This review examines PEGylation from the perspective of developing a commercially viable drug product. The first section focuses on obtaining a pure and well-characterized drug substance. The latter section discusses formulation and manufacturing issues, with an emphasis on analytical methodology that provides the most detailed description of the purity and stability of PEGylated proteins.
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