RP-CAD for Lipid Quantification: Systematic Method Development and Intensified LNP Process Characterization.

Lipid nanoparticles (LNPs) and their versatile nucleic acid payloads bear great potential as delivery systems. Despite their complex lipid composition, their quality is primarily judged by particle characteristics and nucleic acid encapsulation. In this study, we present a holistic reversed-phase (RP)-charged aerosol detection (CAD)-based method developed for commonly used LNP formulations, allowing for intensified LNP and process characterization.

Modeling the impact of amino acid substitution in a monoclonal antibody on cation exchange chromatography.

A vital part of biopharmaceutical research is decision making around which lead candidate should be progressed in early-phase development. When multiple antibody candidates show similar biological activity, developability aspects are taken into account to ease the challenges of manufacturing the potential drug candidate. While current strategies for developability assessment mainly focus on drug product stability, only limited information is available on how antibody candidates with minimal differences in their primary structure behave during downstream processing.