By Alice Harrison, Global Technical & CMC Director for Analytics, Lonza, and Stuart Jamieson, Global Technical & CMC Director for Downstream Development, Lonza
Bi-specific antibodies (bsAbs) are becoming increasingly prevalent in the landscape of biopharmaceutical manufacturing. While bsAbs share structural similarities with monoclonal antibodies (mAbs), downstream purification faces challenges with bsAb-specific by-products such as mispaired chains, unwanted fragments, and higher aggregation levels. bsAbs present a distinct set of purification challenges due to common molecule characteristics, such as low product yields and high aggregate concentrations, that are not present in mAb processes.
In this article, Stuart Jamieson and Alice Harrison at Lonza discuss the downstream issues that development scientists encounter and the need for rapid method development.