News

Heilbronn, 2018-09-21

Protagen Protein Services is pleased to inform you about our latest publication: A Quantitative MS-based Multiple-attribute Method (MAM) Approach for New Biological Entities and Biosimilar Candidates Presented by a Full Method Qualification for an IgG1 Market Product

presented by Dr. Anke Schnabel, Team Leader Biotherapeutical Analytics, on the occasion of the 15th MASS SPEC 2018, September 9th-12th San Francisco, USA.

(Publications)

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The U.S. Food and Drug Administration (FDA) withdrew its draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars. The FDA withdrew the draft guidance on June 21.

Read more: FDA Withdraws Draft Guidance on Biosimilar Development