Author Archives: USP

Building and demonstrating quality of mAb therapies from the ground up

The demand for monoclonal antibody (mAb) therapies is growing at an unprecedented rate likely due to their proven effectiveness in treating a wide range of illnesses. The recent pandemic is just one example of a situation where the potential of mAbs to reverse even the most severe disease was realized. This bodes well for mAb biosimilar manufacturers ready to bring many more products to market over the next decade. Public impact MAbs had a significant head start over novel technologies…