Achieving Best Product Purity and Recovery:Mixed-Mode Chromatography for Monoclonal Antibody Aggregate Removal

摘要

Advances in monoclonal antibody (mAb) technology have revolutionized the field of biological research. With applications in both research and therapeutics, mAb development is one of the fastest growing sectors in the pharmaceutical industry.Purification of mAbs faces many hurdles, including process challenges related to aggregate formation and removal. Multiple factors can lead to aggregate formation during upstream cell culturing as well as downstream manufacturing. The presence of aggregates can hinder the efficacy of therapeutic mAbs due to their different bioactivity, storage stability, immunoge-nicity, and pharmacokinetic properties relative to the monomeric versions.