Innovations In Purification: Lowering Cost And Accelerating Drug DevelopmentSource: Grace
By Carol Preisig, Ph.D.
Monoclonal antibodies (mAbs) are becoming key therapeutic agents for treating complex diseases, such as rheumatoid arthritis and cancer, as well as niche and rare disorders. Between 2007 and 2012, production of mAbs increased 20.3% annually from 8.2 tons to 20.7 tons. With the development of more mAb candidates, more material is needed for therapeutic testing and treatment. However, purification and characterization of such antibodies is challenging due to structural variations and the very complex nature of these types of proteins. To address the challenges, developers have looked to the workhorse for mAb purification – protein A. Unfortunately, the cost of protein A is considered too high by some, with prices ranging as high as $17,157/L2. Still others argue that the greater limitation is capacity or productivity rather than costs. Protein A capacity issues arise from using porous particles in a xed bed and the fact that the bound protein A ligand itself is large which creates additional intrapore space. Therefore, more innovation is needed to create a ”go to” protein A solution that broadly addresses production of mAb-based therapeutics from preclinical through clinical development and onto commercialization.