​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.

Jan 5, 2022

pH离子淌度试剂
SCX-MS/MS表征 mAb

pH Gradient Buffer
for Characterization of Intact and Subunits

核⼼试剂:
pH离⼦子淌度试剂;BT表面活性剂;IdeS/IdeZ蛋白酶
Key Reagent:
pH Gradient Buffer; BT Surfactant; IdeS Protease

pH离子淌度试剂
SCX-MS/MS表征 mAb

pH Gradient Buffer
for Characterization of Intact and Subunits

Jan 4, 2022

超快速表征 N-聚糖
LC-MS/MS表征技术

Characterization of Released N-Glycans

核⼼试剂:
BT表面活性剂;PNGase F糖苷酶;N-Glycan分子标签
Key Reagent:
BT Surfactant; PNGase F Glycodase; N-Glycan Label

超快速表征 N-聚糖
LC-MS/MS表征技术

Characterization of Released N-Glycans

Jan 3, 2022

MAM 分析⽅法
产品质量属性PQA

MAM Technology for PQA

核⼼试剂:
BT表面活性剂;Trypsin; LysC蛋白酶
Key Reagent:
BT Surfactant; Trypsin and Lys C

MAM 分析⽅法
产品质量属性PQA

MAM Technology for PQA

Jan 2, 2022

样品前处理
eFASP技术

ePAST Method for Sample Preparation

核⼼试剂:
BT表面活性剂;Trypsin; LysC蛋白酶
Key Reagent:
BT Surfactant; Trypsin and Lys C

样品前处理
eFASP技术

ePAST Method for Sample Preparation

Jan 1, 2022

pending

N/A

pending

Dec 31, 2021

pending

N/a

pending