PATfix LNP Switcher Platform
Innovative solution that enables investigation of multiple critical attributes for LNP drug products, without extensive sample preparation or dye requirements.
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The PATfix® LNP Switcher Platform is chromatographic system developed to meet the analytical needs of complex lipid nanoparticle (LNP) formulations, including those carrying multiple types of cargo such as mRNA, mcDNA, gRNA, siRNA, or small molecules. It supports fast and comprehensive analysis without requiring dyes or extensive sample preparation—making it well-suited for process development, formulation screening, and post-formulation stability testing.
The system allows for direct analysis of LNP samples through simple dilution, minimizing sample handling while preserving structural integrity. With its sensitive detector combinations of UV, MALS, and others, PATfix® enables the simultaneous assessment of key quality attributes including cargo encapsulation, particle size, integrity, heterogeneity, and purity. Its client-server software architecture supports remote access and collaborative data review, streamlining analytical workflows across teams.
Key Features & Benefits
- Compatible with multi-cargo LNPs (e.g., Cas9 + gRNA)
- Requires only sample dilution—no dyes or pre-treatment needed
- Assesses cargo encapsulation efficiency, heterogeneity, integrity, size, and purity in a single run
- Sensitive detector suite for low sample consumption
- 21 CFR part 11 compliant, remote-access software
Applications
- Characterization of LNPs with single or multiple nucleic acid cargos
- LNP process development and formulation screening
- Post-formulation drug product stability testing
- Analytical support for RNA-based therapeutics and gene therapy products
- Regulatory compliance and reporting
