G-CSF is a cytokine which is involved in triggering the production of white blood cells (neutrophils) and their release from the bone marrow.

Filgrastim is a recombinant form of the human granulocyte colony-stimulating factor (G-CSF). It is a 175-amino-acid polypetide with two disulfide bridges, which is expressed in E.coli. Lenograstim, a variant expressed in Chinese hamster ovary (CHO) cells, represents a recombinant glycoprotein. There are already a number of Filgrastim biosimilars and biobetters on the market. Pegfilgrastim is a variant coupled to a polyethylene glycol (PEG) molecule.

We have long-standing experience in the analysis of different variants of G-CSF originators, biosimilars and biobetters.

To support the development of filgrastim biosimilars or biobetters, Protagen has set up an analysis program in accordance with ICH Q6B guidelines, including method setup, validation of customer-specific methods, and release testing. This package includes:

  • Volume determination
  • Bacterial endotoxin testing
  • Sterility testing
  • pH determination, opalescence and coloration
  • Biological activity testing
  • Protein identification by western blotting
  • Protein identification by peptide mapping
  • Protein concentration
  • IEF

 Compendial Bioassay provided by a strategic partner:

  • Proliferation Assay, statistical analysis by PLA

 

Your contact for G-CSF at Protagen Protein Services GmbH

Martin-Blueggel 150x100px

Martin Blüggel

Chief Executive Officer (CEO)
Our business development team will be happy to assist you with your project.

Phone: +49 (0) 231 9742-6100
Email: salesproteinservices@ProtagenProteinServices.com