Purity analysis for intact monoclonal antibodies and fragments

Monoclonal antibodies (mAbs) are well-established therapeutics, with a variety of different analytical methods associated with purity analysis. An analytical technique common for mAb purity is reversed phase LC (RPLC). This is a primary technique utilized for mAbs because of its relatively short analysis time, with high resolution, and its ability to separate hydrophobic variants such as oxidation, glycoforms, and lysine variants. As such, intact reversed phase methods can be implemented during lead selection and optimization, and on to downstream, including stability-indicating methods and quality control lot release. One particularly appealing aspect of analysis by intact reversed phase, is the capability of implementing a “platform” method.