Chemical and Enzymatic Site Specific PEGylation of hGH: The Stability and in vivo Activity of PEG-N-Terminal-hGH and PEG-Gln141-hGH Conjugates

Macromol Biosci. 2016 Jan;16(1):50-6. doi: 10.1002/mabi.201500282. Epub 2015 Sep 9.

Abstract

The use of therapeutic proteins is often impaired by their short in vivo half-lives. PEGylation has been exploited to enhance protein stability and to prolong the pharmacokinetic. The biophysical characterization of two site-specific mono-PEGylated forms of human growth hormone (hGH)--chemically N-terminal PEGylated hGH (PEG-Nter-hGH) and enzymatically Gln141 PEGylated hGH (PEG-Gln141-hGH) via transglutaminase--is outlined here and their pharmacodynamics are compared. The thermal stability of PEG-Nter-hGH was increased with respect to that of hGH and PEG-Gln141-hGH. Pharmacodynamic studies in rats showed that a single injection of the conjugates had a better or comparable potency with respect to a daily hGH on a week schedule in terms of weight gain, femoral length, and tibial diaphysis width.

Keywords: PEGylation; enzymatic PEGylation; hGH; transglutaminase.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Growth / drug effects*
  • Half-Life
  • Human Growth Hormone / chemistry
  • Human Growth Hormone / metabolism*
  • Human Growth Hormone / pharmacokinetics
  • Human Growth Hormone / pharmacology
  • Male
  • Polyethylene Glycols / chemistry
  • Polyethylene Glycols / metabolism*
  • Protein Stability
  • Rats
  • Transglutaminases / metabolism

Substances

  • Human Growth Hormone
  • Polyethylene Glycols
  • Transglutaminases