Assess top-down approaches for antibody characterization

With the continuing growth in the development and adoption of mAbs for a wide range of therapeutic uses, there is increasing demand for higher quality characterization of these complex species.   The Consortium has launched this inter-laboratory study to assess the state of the art for top-down mass spectrometry determination of monoclonal antibody structure and modifications

The participants in this study will utilize several workflows such as top-down and middle-down sequencing, intact mass analysis, and profiling of modifications to elucidate structural details on three monoclonal antibodies: Sigma SILu™ Lite mAb standard, NIST mAb standard, and a commercially available therapeutic mAb. Researchers will be provided the intact species as well as the mAb subunits enzymatically prepared with Genovis’ IdeS/Fabricator® and KGP/GingisKHAN®. The study is being coordinated by Yury Tsybin of Spectroswiss Sarl, Joe Loo of UCLA, and Kristina Srzentic of Northwestern University.

A summary of the results will be prepared and submitted for publication in the Fall of 2017.