生物制药 | Biopharma
所有生物制品生产许可申请 (BLA) 中，LC/MS技术解决方案已成为生物治疗蛋白表征的重要工具。生物治疗蛋白的关键质量属性 (CQAs） 包括Native Intact and subunit结构；电荷异质性（CVs）；N-聚糖型；宿主细胞蛋白残留（HCPs)和产品质量（肽段）多属性等，用于确定产品质量和临床疗效。
Mass spectrometry (MS) has become important tool in the characterization of protein-based biopharmaceuticals. The depth of information obtained from MS-based techniques is critical in the characterization of these complex antibody and has lately been included in almost all biologics license applications (BLAs). the Critical Quality Attributes includes characterization of Charge Variant(CVs), subunits of Intact glycoproteins in native or denature condition; of the released N-Glycans using the Labelling reagents by HILIC/MS; Host Cell Proteins impurities(HCPs) quantify. During the manufacturing process and development requires deep understanding at the molecular peptides level of any Products Quality Attributes(PQAs), the analytical approach referred to as multi-attribute methods(MAM) has gained considerable interest in biopharmaceutical industry. MAM is a MS analytical platform for monitoring consistencey and behavior of biopharmaceutical PQAs.
