The number of biotherapeutic drugs including mAbs and their related products such as antibody-drug conjugates (ADCs) has been growing rapidly, particularly in the last decade. The development and commercialization of these complex entities is a complicated process and requires a significant amount of effort and capability—especially in chromatographic separations. This has created a need for chromatographers to have effective strategies for LC separations of large (>50,000 MW) and complex proteins, such as monoclonal antibodies (mAbs), and their variants.
In this web seminar, we will discuss how to approach your method development strategy by adjusting various parameters of your separation to ensure that you are seeing more of the variants of your complex proteins. These parameters include: pore size, bonded-phase chemistry, mobile phase modifiers, mobile phase additives, and column temperature. Systematic selection and adjustment of these variables leads to improved resolution of highly similar protein variants. An example of this approach is high-resolution intact protein LC–MS analysis of difficult IgG mixtures, such as the complex mixtures of lower abundance free sulfhydryl variants present in therapeutic mAbs.
