BioPharm International Supplements, August 2010 - BioPharm International

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BioPharm International Supplements, August 2010
Article
Using NMR Spectroscopy to Obtain the Higher Order Structure of Biopharmaceutical Products
By Yves Aubin , Christopher Jones , Darón I. Freedberg
Simple methods can characterize polysaccharide vaccines and recombinant cytokines at high resolution.
Rapid Assessment of Molecular Similarity between a Candidate Biosimilar and an Innovator Monoclonal Antibody Using Complementary LC–MS Methods
By Martin Gilar, PhD , Hongwei Xie, PhD , Asish Chakraborty, PhD , Joomi Ahn , Ying Qing Yu, PhD , Weibin Chen, PhD , St John Skilton, PhD , Jeffery R. Mazzeo, PhD , Deepalakshmi P. Dakshinamoorthy
Intact protein LC–MS detected a mass variance of 62 Da and peptide mapping located a difference of two amino acids.
Capturing Conformational Changes in Biotherapeutics by Hydrogen Deuterium Exchange and UHPLC–MS
By Joomi Ahn , St John Skilton, PhD
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.
Protein Characterization Through the Stages
By Lisa Crossley, PhD
Biomanufacturers should follow a risk-based approach to decide which methods to use to characterize their products.
Biophysical Characterization for Product Comparability
By Qin Zou, PhD , Yin Luo, PhD
Spectroscopic methods such as circular dichroism can detect subtle differences in higher order structure before and after changes in process and formulation.

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