The Sugar is the Key

摘要

Protein biologies now represent a significant share of pharmaceutical sales and future growth potential, particularly in an era of increasing patent expirations. A range of analytical methods is required to determine the purity, identity and integrity of protein biologies at multiple points along the manufacturing process,from cell culture to downstream purification, product characterisation and lot release. Most protein drugs developed to date are glycoproteins, including monoclonal antibodies (mAbs).