曲妥珠单抗
单克隆抗体
化学
单克隆
单体
圆二色性
抗体
色谱法
药理学
乳腺癌
癌症
医学
聚合物
内科学
结晶学
免疫学
有机化学
作者
Ritesh M. Pabari,Benedict K. Ryan,Wazir Ahmad,Zebunnissa Ramtoola
出处
期刊:Current Pharmaceutical Biotechnology
[Bentham Science]
日期:2013-02-01
卷期号:14 (2): 220-225
被引量:7
标识
DOI:10.2174/138920113805219322
摘要
A major limitation of biological therapeutics is their propensity for degradation particularly in aqueous solutions hence resulting in their short shelf-life. In this study, the stability of trastuzumab (Herceptin®) intravenous (i.v.) solutions, an IgG1 monoclonal antibody (mAb), indicated for the treatment of HER2 positive breast cancer, stored under refrigerated conditions, was evaluated over 28 days. No change in visual appearance or average particle size was observed. The pH values of the trastuzumab i.v. solutions remained stable over time. Interestingly, no change in trastuzumab monomer concentration was observed throughout the 28-day study, as determined by SEC-HPLC. SDSPAGE showed only a monomer band corresponding to the molecular weight of trastuzumab. Circular dichroism spectra obtained following 28-day storage demonstrated integrity of the secondary structural conformation of trastuzumab. Results from this study show that trastuzumab i.v. solutions remain physically and structurally stable on storage at 2-8°C for 28 days. These findings suggest that trastuzumab in solution may not be as sensitive to degradation as expected for a mAb and therefore may have important implications in extending trastuzumab shelf life for clinical use and reducing associated healthcare cost.
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