Protein charge homogeneity can have a significant effect on the structure, stability, binding affinity, and efficacy of a biotherapeutic drug. Speed and accuracy are key criteria for laboratories performing charge variant profiling. Especially in contract research organizations who deliver confident, fast analytical services to the biopharmaceutical and biosimilar industry. Ion exchange chromatography (IEX) is often used for protein charge variant profiling, either by salt gradient or pH gradient and can be easily implemented for routine analysis with buffer kits, correct column selection and easy-to-use software.
Charge variant analysis workflow
Identification and separation of charge variants is performed rapidly and reliably with full Vanquish UHPLC solutions. Separations of monoclonal antibody variants can be challenging as they are complex molecules and can differ by as little as one charge. The use of a pH gradient-based elution can be easily implemented with buffer kits and lead to faster, more robust and less challenging separations than salt-based elutions with better resolution and sensitivity. Additionally the column chemistry is critical for optimized separations. The unique nonporous pellicular resin used in MAbPac SCX-10 provides high resolving power, permitting the separation of monoclonal antibody variants that differ by as little as one charge.