BioPharm International-08-02-2010

Structure, Comparability, and Biosimilars: Advances in Protein Characterization

By providing information on the relative accessibility of locations within a protein, HDX by mass spectrometry opens new windows into the higher order structure of biomolecules.

Biomanufacturers should follow a risk-based approach to decide which methods to use to characterize their products.

Spectroscopic methods such as circular dichroism can detect subtle differences in higher order structure before and after changes in process and formulation.

Simple methods can characterize polysaccharide vaccines and recombinant cytokines at high resolution.

Intact protein LC–MS detected a mass variance of 62 Da and peptide mapping located a difference of two amino acids.