C-termini Analysis of Monoclonal Antibody Fragmentation

Fragmentation of therapeutic monoclonal antibodies (mAbs) is a critical quality attribute (CQA) that needs to be monitored and controlled during the biopharmaceutical drug development. Fragmentation of a protein is a result of either chemical or enzymatic reactions, leading to the cleavage of protein backbones. Fragmentation can occur through the entire mAb lifespan, from protein production in the bioreactor, purification process, storage, to blood circulation and clearance. Depending on the cleavage sites, fragmentation could affect the function of mAbs.