Heilbronn, 2018-11-09

Hot off the press! The new Jubilee Edition of the 20th Guide to German Biotech Companies with 100 company profiles and the BIOCOM AG report data about the German Biotechnology Sector 2018 is now available. Find Protagen Protein Services with our analytical service portfolio starting page 158.

Heilbronn, 2018-10-29

Leah Christl, PhD, associate director for therapeutic biologics, director of the therapeutic biologics and biosimilars staff in the office of new drugs in the FDA’s Center for Drug Evaluation and Research reviewed the status of some of the planned deliverables for the 4 major elements of the Biosimilar Action Plan during the fifth DIA Biosimilars Conference, held October 22 to 23, 2018, in London, United Kingdom.

Read more: FDA's Leah Christl Provides an Update on the Biosimilar Action Plan

Heilbronn, 2018-10-22

Last week, October 16th marked European patent expiry for AbbVie’s blockbuster anti–tumor necrosis factor drug, adalimumab (Humira), and multiple competitors stand ready to launch their biosimilar products on, or shortly after, that date.

Read more: On the Eve of Humira's Patent Expiry, Europe Prepares for Biosimilar Adalimumab

Heilbronn, 2018-10-08

Last week, the European Medicines Agency (EMA) and the European Commission have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU).

Read more: Improving understanding of biosimilars in the EU

Heilbronn, 2018-09-24

Protagen Protein Services is pleased to inform you about our latest publication: A Comparison of UPLC and CE-based Approaches for Glycan Profiling of Biotherapeutic Proteins- Challenges for the Fast Characterization of New Biological Entities (NBEs) and Biosimilar Candidates

presented by Dr. Thomas Schröter, Application Specialist, on the occasion of the 20th CE Pharm 2018, September 9th-12th San Francisco, USA. (Publications)

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)

Read more: 15th MASS SPEC 2018: See our latest publication

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