Method optimization of purity analysis of a Fc-Fusion protein by reversed phase HPLC

A primary analytical technique for purity for recombinant proteins is reversed phase LC (RPLC). This is a simple, robust methodology with a relatively short analysis time, with high resolution, its ability to separate hydrophobic variants such as oxidation, glycoforms, and clipping. As such, RPLC is a common analytical approach for monoclonal antibodies (mAbs), especially considering it can be implemented at both intact and subunit levels without extensive method optimization when combined with a bioZen™ 2.6 µm WidePore C4 LC column.