The landscape of biopharmaceutical manufacturing is changing, with complex molecules such as bi-specific antibodies (bsAbs) becoming increasingly prevalent. bsAbs are a large, structurally diverse family of molecules designed to recognise two targets and globally there are over 230 in development as promising therapies for cancer and other diseases. While they 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. Stuart Jamieson and Alice Harrison discuss the downstream issues that development scientists encounter and the need for rapid method development.

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