期刊
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
卷 1065, 期 -, 页码 119-128出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jchromb.2017.09.033
关键词
Therapeutic monoclonal antibodies; Isoelectric points; Charge variants; Imaged capillary isoelectric focusing; Cation exchange chromatography; Developability; mAbs
资金
- Swiss National Science Foundation [31003A 159494]
Despite the popularity of therapeutic monoclonal antibodies (mAbs), data relative to their ionic physico-chemical properties are very scarce in the literature. In this work, isoelectric points (p/s) of 23 Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved mAbs were determined by imaged capillary isoelectric focusing (icIEF), and ranged from 6.1 to 9.4. The obtained values were in good agreement with those calculated by both Vector NTI and MassLynx softwares. icIEF can therefore be considered as a reference technique for such a determination. The relative percentages of acidic and basic variants determined by cation exchange chromatography (CEX) using both salt- and pH-gradients were comprised between 15% and 30% for most mAbs and were in good agreement with each other, whereas generic icIEF seems to overestimate the amount of acidic charge variants in mAb products. To our knowledge, this is the first study focusing on the ionic properties of a wide range of FDA and EMA approved reference mAbs, using both generic chromatographic and electrophoretic methodologies. To illustrate the interest of the study for mAb developability purposes, ionic properties of a clinical mAb candidate (dalotuzumab) were also investigated.
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