BioPharm International Supplements, August 2010 - BioPharm International

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BioPharm International Supplements, August 2010
Peer-Reviewed Research
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.
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.
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.
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.
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.

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