An integrated analytical approach to lipase risk management in biologics development
Lipase-family host-cell proteins (HCPs) may retain enzymatic activity that can degrade polysorbate excipients such as PS20 and PS80, with potential implications for product quality and stability. Conventional total HCP measurements alone may not reveal whether residual lipases remain active.
This whitepaper explores how Samsung Biologics combines LC–MS-based HCP profiling with a targeted lipase activity assay to provide a more complete, risk-based view of lipase-related stability concerns.
Key highlights include:
Assess lipase-related risk based on functional activity
Inform DSP development, resin selection, and process optimization
Support control of polysorbate-related stability risk
Discover how an integrated analytical approach can help assess lipase-related stability risks and support more informed process development and control.
Lipase-family host-cell proteins (HCPs) may retain enzymatic activity that can degrade polysorbate excipients such as PS20 and PS80, with potential implications for product quality and stability. Conventional total HCP measurements alone may not reveal whether residual lipases remain active.
This whitepaper explores how Samsung Biologics combines LC–MS-based HCP profiling with a targeted lipase activity assay to provide a more complete, risk-based view of lipase-related stability concerns.
Key highlights include:
- Assess lipase-related risk based on functional activity
- Inform DSP development, resin selection, and process optimization
- Support control of polysorbate-related stability risk
Discover how an integrated analytical approach can help assess lipase-related stability risks and support more informed process development and control.
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