News

Heilbronn, 2018-08-01

Protagen Protein Services is pleased to invite you to our co-organized event in cooperation with fleming: CMC Analytical Comparability Training 8.-9.10.2018 Vienna, Austria Trend Hotel Doppio

Learn how to define protein analytical program & critical quality attributes, to design an analytical strategy for comparability studies, the global context of biologics, biosimilars & bio-betters, and new developments in function relationship.

Read more: CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars

Heilbronn, 2018-07-23

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

Read more: Monograph for Etanercept is published

Heilbronn, 2018-07-10

The U.S. Food and Drug Administration (FDA) withdrew its draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars. The FDA withdrew the draft guidance on June 21.

Read more: FDA Withdraws Draft Guidance on Biosimilar Development