1B-O1-1545 PDF
Characterization and Quality Control of Protein Therapeutic with Mass Spectrometry
Regulators are encouraging the biopharmaceutical industry to improve biophysical characterization of protein therapeutics and to focus on CQA (Critical Quality Attributes) when performing drug quality and safety evaluations. Currently some BioPharma companies are working to develop MS-based quantitation method for the release test in QC and several current methods can be replaced by a single multi-attribute MS-based method with an emphasis on biologically relevant attributes. This session explores the usage of LC-MS system in QC.