In the dynamic field of gene therapy, advanced lipid nanoparticle (LNP) bioanalysis is proving pivotal for RNA-based therapeutics. Inotiv, through the expertise of scientists like Matt Westfall and Mike Heaven, offers a comprehensive, integrated approach. Their proteomics group, led by Westfall, specializes in protein analysis via mass spectrometry, offering both targeted quantification and global pathway insights crucial for assessing gene therapy impact. Heaven's team focuses on high-resolution mass spectrometry for LNP characterization, precisely measuring every component—from individual lipids and their ratios to encapsulated functional RNA and its encapsulation efficiency.
This "one-stop-shop" service supports clients from initial therapeutic idea to Investigational New Drug (IND) application. Inotiv's unique value lies in its manufacturing-level qualification of LNPs, addressing critical issues of consistency in LNP manufacture and cargo composition. They provide detailed high-resolution data on lipid and RNA impurities and modifications, often revealing unanticipated but valuable information. By analytically qualifying LNPs and offering in vitro and in vivo model testing alongside proteomic analyses, Inotiv quantifies delivered gene expression at the protein level, directly linking LNP design to phenotypic outcomes. This holistic approach, which also examines critical factors in LNP design like lipid panel impact on toxicology and delivery efficiency, helps clients overcome industry roadblocks and advance their RNA-based gene therapies.
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