Pegylation, as method of production prolonged forms of biopharmaceutical drugs (pegylated granulocyte colony-stimulating factor as case of study)

Abstract

By now the pegylation of biologically active molecules including proteins with an inert hydrophilic polymer polyethylene glycol (PEG) is an important area in the new generation of prolonged-action pharmaceutical preparations. The conjugated molecules usually have an improved pharmacokinetic profile, including reduced renal clearance, additional protection from the proteolytic enzymes and reduced immunogenicity, thus preserving the in vivo activity of the native preparation in the human body for a longer time. This review is focused on the example of the pegylation of recombinant human granulocyte colony-stimulating factor (G-CSF) and gives the opportunity to have a look at different ways of pegylation and the mechanism of this reaction. Besides, the review describes the different types of reactive PEG for the specific conjugation to biological molecules and benefits and disadvantages of these reagents.

Keywords

• polyethylene glycol (peg), biopharmaceutical drugs, granulocyte colony-stimulating factor (g-csf), modification, cytokines, pharmacokinetic profile.