The critical need to rapidly develop new biological therapeutics was emphasized during the COVID-19 pandemic, prompting a sea-change in the speed with which development of complex biological medicines occurs. In parallel, the increasing demand for new molecular formats, such as multi-specific antibodies, to tackle a wide range of disease modalities has led to challenges in expediting the development of the analytical methods and production processes required to bring these new therapeutics to the clinic. In this article Stuart Jamieson and Alice Harrison at Lonza discuss strategies to overcome these challenges and meet the demand to accelerate the speed to clinic of multi-specific, multi-chain new molecular format therapeutics.

Authors: Stuart Jamieson, Global Technical and CMC Director for Downstream Development; Alice Harrison, Global Technical Director (CMC and Analytics)

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