Antibody charge variants have gained great attention in the biotech industry due to their potential influence on stability and biological activity. Slight differences in the relative proportions of charge variants pose a challenge to demonstrating product comparability. The “mAbs” article describes how scientists gained insight into the impact on biological activity and pharmacokinetics (PK) of monoclonal antibody (mAb) charge heterogeneity.
“Charge variants are a continuous unknown in process development of monoclonal antibodies, yet rarely is it possible to generate enough of this material to perform crucial analysis at PK level. Displacement chromatography using SACHEM displacers offers the unique ability to isolate and concentrate these minor components,”says Dr. Pat McAtee, Senior R&D Chemist at SACHEM, Inc.
SACHEM has ion-exchange displacers commercially available and recently announced a new line of SBS Quick Start™ protein separation and purification kits using SACHEM Expell™, Isolis™ and Propell™ displacers. This line of “all-inclusive” packages provides a convenient introduction and opportunity to evaluate displacement chromatography for different purification challenges.