Contact

What are you looking for?

Primary and Higher-Order Structural Characterization Strategy for Biosimilarity Assessment

May 23, 2016
Download now

This article addresses some issues involved in meeting regulatory characterization expectations for biosimilars by answering the following questions: What regulatory guidelines are associated with structural characterization and comparability/biosimilarity testing? What complicates the characterization of complex (glyco)protein products? When is analytical characterization required? And which techniques (old and new) are suitable for this application?

344 x 492 White Paper Primary

News & Insights

  • Groupe SGS France

29 Avenue Aristide Briand,

Cedex, 94111,

Arcueil, Val-de-Marne,

France