5 years ago

Determination of isoelectric points and relative charge variants of 23 therapeutic monoclonal antibodies

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 (pIs) 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.

Publisher URL: www.sciencedirect.com/science

DOI: S1570023217313880

You might also like
Discover & Discuss Important Research

Keeping up-to-date with research can feel impossible, with papers being published faster than you'll ever be able to read them. That's where Researcher comes in: we're simplifying discovery and making important discussions happen. With over 19,000 sources, including peer-reviewed journals, preprints, blogs, universities, podcasts and Live events across 10 research areas, you'll never miss what's important to you. It's like social media, but better. Oh, and we should mention - it's free.

  • Download from Google Play
  • Download from App Store
  • Download from AppInChina

Researcher displays publicly available abstracts and doesn’t host any full article content. If the content is open access, we will direct clicks from the abstracts to the publisher website and display the PDF copy on our platform. Clicks to view the full text will be directed to the publisher website, where only users with subscriptions or access through their institution are able to view the full article.