An Integrated Analytical Approach To Lipase Risk Management In Biologics Development

By Kyeyeon Hur, Head of CMC Support; Jimin Kim, Director of Analytical Development; Minjeong Lee, Senior Scientist in Analytical Platform Development; Soojeong Oh | Senior Scientist in Structure Analytics; and Woojung Jun, Scientist in Structure Analytics

Total HCP testing provides a useful aggregate measure of residual impurity burden, but it cannot determine whether lipase-family proteins are still enzymatically active. That gap matters: even trace levels of functional lipase can degrade PS20 or PS80, shortening drug shelf life in ways that aggregate measurements alone may not anticipate or detect.

This whitepaper, authored by analytical and CMC scientists including Kyeyeon Hur, Senior Director of CMC, and Jimin Kim, Director of Analytical Development, makes the case for treating lipase activity as a distinct risk indicator rather than an extension of total HCP monitoring. It describes why detecting a lipase-family protein by LC–MS and confirming it is enzymatically active are two different questions, and why the answers can point in different directions.

The paper also presents resin screening data, case studies from a late-phase technology transfer and a bispecific antibody program, and the methodology behind a fluorescence-based functional lipase assay. Explore the full whitepaper to see how the two methods work together in practice.