The monograph for Etanercept (2895) is published in the Supplement 9.5 of the European Pharmacopoeia effectively July 1st, 2018.

We appreciate the publication of European Pharmacopoeia Etanercept monograph, a first of its kind of a complex Antibody. Methods like N-Glycan HPLC, Peptide Mapping, Sialic Acid Content, SEC and 1D PAGE will give good insights in quality attributes, however there is much more than these to justify Biosimilarity.

https://www.edqm.eu/en/news/ph-eur-monograph-etanercept-2895-be-published-soon-supplement-95

https://www.edqm.eu/en/biotherapeutics 

Contact us to learn how Protagen Protein Services can support your biotherapeutical development process. Our experts are happy to discuss your request.