方案摘要
方案下载应用领域 | 生物产业 |
检测样本 | 其他 |
检测项目 | |
参考标准 | / |
关键词:747022G, Antibody, IgG, Antibody Drug, Biopharmaceutical, Aggregate, TSKgel G3000SWXL, SEC, UV 检测器
IgG, which is a type of antibody, is used as a drug substance for antibody drugs. It is known that IgG may form dimer, trimer, and aggregates due to mechanical stress in each process during manufacturing and environmental factors during transportation and storage. Since aggregates in antibody drugs can reduce drug efficacy and cause side effects, it is necessary to evaluate monomer, multimers, and aggregates for quality control. In 2014, the U.S. Food and Drug Administration (FDA) has provided guidance on the evaluation of immunogenicity of therapeutic protein products and recommended that the validity of each analysis result should be judged while comparing the results using multiple methods (Orthogonal Method) with different measurement principles for protein aggregates contained in biopharmaceuticals. This time, we show the results of measuring human serum-derived IgG reagent by size exclusion chromatography (SEC), which is one of the analytical methods for aggregates, and separating and detecting monomer, multimers, and aggregates.
Results
Figure 1 shows a UV chromatogram of a protein standard sample. As reference data, an RI chromatogram is also shown, which was measured by connecting an RI detector (RI-4030) downstream of the UV detector.
HPLC 中的采样频率、响应时间和柱外效应
基于抗体的药物强制降解研究中聚集物和降解产物的SEC监测
用CD光谱法评估VHH抗体的高阶结构、稳定性和相似性
相关产品
JASCO圆二色光谱仪CD J-1500
JASCO振动圆二色光谱仪VCD FVS-6000
JASCO圆偏振荧光光谱仪CPL-300
JASCO高效色谱仪LC-4000
jascoRFT-6000傅立叶变换红外拉曼光谱仪
JASCO红外显微镜IRT-7200
MSV-5000显微紫外可见近红外分光光度计
jasco紫外可见分光光度计 V-700
JASCO FTIR-4000傅立叶变换红外光谱仪
JASCO 全自动数字旋光仪P-2000
JASCOFP-8000系列荧光光谱仪
JASCO SFC4000超临界流体色谱仪
JASCONRS5000/7000共聚焦激光拉曼光谱仪
JASCO V-7000系列紫外可见近红外分光光度计
JASCO傅立叶变换红外光谱仪FT/IR-6000
关注
拨打电话
留言咨询