Reproducible preparation and effective separation of PEGylated recombinant human granulocyte colony-stimulating factor with novel "PEG-pellet" PEGylation mode and ion-exchange chromatography

J Biotechnol. 2005 Jul 21;118(1):67-74. doi: 10.1016/j.jbiotec.2005.02.015.

Abstract

A novel preparation for polyethylene glycol (PEG) derivatives and chromatographic separation procedure of the PEGylated recombinant human granulocyte colony-stimulating factor (rhG-CSF) were designed to evaluate the reproducibility and scalability at large laboratory-scale level. The new "PEG-pellet" PEGylation mode was successfully applied to control the pH fluctuation during the conjugation reaction, a general problem in traditional liquid-phase conjugation mode. Moreover, two consecutive ion-exchange chromatography steps were successfully used to separate and purify the PEGylated rhG-CSF. Cation-exchange chromatography was firstly applied to separate PEGylated rhG-CSF from intact rhG-CSF, followed by anion-exchange chromatography to obtain individual PEG-rhG-CSF species (mono-, di- and tri-PEGylated rhG-CSF) and remove the excess free PEG. Furthermore, the molecular weight of individual PEGylated rhG-CSF was identified by matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometry and SDS-PAGE, and cell proliferation activity in vitro was detected by MTT assay using NFS-60 cell.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Cell Line, Tumor
  • Cell Proliferation
  • Chemical Fractionation / methods
  • Chromatography, Ion Exchange / methods*
  • Granulocyte Colony-Stimulating Factor / biosynthesis
  • Granulocyte Colony-Stimulating Factor / chemistry
  • Granulocyte Colony-Stimulating Factor / isolation & purification*
  • Humans
  • Leukemia, Myeloid / genetics
  • Leukemia, Myeloid / metabolism*
  • Leukemia, Myeloid / pathology
  • Mice
  • Polyethylene Glycols / chemistry
  • Polyethylene Glycols / isolation & purification*
  • Recombinant Proteins / chemistry
  • Recombinant Proteins / isolation & purification*
  • Reproducibility of Results

Substances

  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Polyethylene Glycols