1B-O1-1545 PDF
質量分析によるバイオ医薬品の特性解析と品質管理への応用
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.