Erythropoietin (EPO) is mainly used for the treatment of anemia resulting from different diseases such as chronic kidney disease or from the treatment of cancer or from other critical illnesses. Its main function is promoting red blood cells by protecting these cells from apoptosis.

EPO is a 165 amino acid protein with a high glycosylation ratio of about 40% by weight. The glycosylation consists of N- (three sites) and O-glycans (one site). The glycans are highly branched and carry sialic acids at the branch ends. This degree of sialic acids is an important regulator for the serum half-life and thus for the efficacy of the drug.

Most EPO drug products are recombinantly produced in CHO-cells, but also BHK or in a human fibrosarcoma cell line (HT-1080 derivative). Amgen marketed the first recombinant EPO in 1989 under the trade names Epogen or Epoetin.

Meanwhile, a large number of EPO variants and biosimilars are marketed, such as Darbepoetin, which carries additional glycosylation sites and order to improve the pharmacodynamics.

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

To support the development of EPO 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 protein quantification, characterizing the protein primary structure, analysis of N- and O-glycosylation, sialic acid content, antennarity and protein modifications.

Specific Bioassay provided by a strategic partner:

  • Proliferation Assay, statistical analysis by PLA

 

    Your contact for Erythropoietin 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