An Integrated Analytical Approach to Lipase Risk Management in Biologics Development
Samsung Biologics' Kyeyeon Hur, Jimin Kim, Minjeong Lee, Soojeong Oh, and Woojung Jun explain how combining LC–MS host-cell protein (HCP) profiling with targeted lipase activity testing can help development teams identify residual lipase-family HCPs, assess their functional activity, guide downstream optimization, and manage product stability risk.