2 - The case for protein PEGylation

Abstract

Many limitations of protein-based medicines have been shown clinically to be alleviated by the covalent conjugation of poly(ethylene glycol) (PEG) in a process known as protein PEGylation. There are at least 15 registered PEGylated products with more in clinical development. Protein PEGylation is generally used to extend the protein circulation time as are several other strategies and polymers (e.g., Fc-fusion, glycoengineering). Analogous to these other half-life extension approaches, PEGylation increasingly relies on recombinant engineering to make more homogeneous PEG–protein conjugates. PEGylated protein products continue to be approved, so it is expected that PEGylation will continue to contribute to the development of new products. This chapter describes the place of protein PEGylation in the context of half-life extension technologies that are available.