Overlooking the intricacies of antibody characterization beyond the antibody sequence leads to unanticipated challenges during downstream development and IND submissions. Potential concerns may emerge related to production quality, including post-translational modifications (PTMs), sequence variants, and cell culture contaminants. As such, in-depth antibody characterization is best conducted early and often in the developmental pipeline.
What are the necessary steps to ensure the development of high-quality antibodies?
The initial steps involve elucidating the primary amino acid sequence of the antibody, pinpointing its binding site on the antigen, as well as its binding kinetics. Prior to advancing to preclinical testing, it is essential to assess the quality and purity of the generated antibodies. This often entails PTM and in-depth glycan analysis, identifying sequence variants, and conducting host-cell protein analysis.
In this webinar, we explore mass spectrometry-based techniques designed for complete antibody characterization. We walk through a streamlined workflow for total antibody characterization, which includes understanding the structure and function of the antibody, to evaluating the overall quality of antibody production.