Paborji M, Pochopin N L, Coppola W P, Bogardus J B
Bristol-Myers Squibb Company, Syracuse, New York 13221.
Pharm Res. 1994 May;11(5):764-71. doi: 10.1023/a:1018948901599.
Chimeric L6 is a mouse-human monoclonal antibody specific for tumor cell-associated antigens. The factors affecting the physical and chemical stability of chimeric L6 were assessed at elevated temperatures (30-60 degrees C) and by multiple freezing and thawing. Three routes of degradation were observed: chemical degradation to smaller molecular weight species, irreversible aggregation, and formation of a reversible dimer. The specific pathway depended on the stress condition applied and the pH, with maximal overall stability to both thermal stress and multiple freezing/thawing observed at about pH 5.5. Other factors including antibody concentration, buffer concentration, NaCl concentration, and agitation had minimal influence on the stability. Commonly used sugars, polyhydric alcohols, and amino acids effectively prevented freeze/thaw-induced aggregation.
嵌合L6是一种针对肿瘤细胞相关抗原的鼠-人单克隆抗体。在升高的温度（30-60摄氏度）下以及通过多次冻融评估了影响嵌合L6物理和化学稳定性的因素。观察到三种降解途径：化学降解为分子量较小的物质、不可逆聚集以及形成可逆二聚体。具体途径取决于所施加的应激条件和pH值，在约pH 5.5时观察到对热应激和多次冻融的总体稳定性最高。包括抗体浓度、缓冲液浓度、NaCl浓度和搅拌在内的其他因素对稳定性的影响最小。常用的糖类、多元醇和氨基酸可有效防止冻融诱导的聚集。
