Monoclonal Antibody Development and Physicochemical Characterization by High Performance Ion Exchange Chromatography

Monoclonal antibodies (mAbs) represent a significant portion of products in the biopharmaceuticals market (Reichert, 2011; Scolnik, 2009). mAbs have been developed to treat a variety of indications to address significant unmet medical needs (Waldmann, 2003; Reichert & Valge-Archer, 2007; Ziegelbauer et al., 2008), and are generally target-specific and well tolerated with a relatively long half-life, contributing to the success of the molecule class for drug development (Scolnik, 2009). Of the classes of antibodies, or immunoglobulins, IgG1 is the most common immunoglobulin used for pharmaceutical and biomedical purposes (Reichert et al., 2005); however, other immunoglobulin types (e.g., IgG2, IgG4) and mAb-related products (e.g., Fc-fusion proteins, Fabs, etc.) are also being used for therapeutic purposes (Hudson & Souriau, 2003).