nuvalore Develops Robust, Stability-Indicating Analytics for mRNA-LNP Programs

Leimen, Germany – GMP-certified pharmaceutical quality control laboratory nuvalore GmbH has developed stability-indicating analytical strategies for mRNA–lipid nanoparticle (mRNA-LNP) systems, supporting characterization, release, and stability assessment across preclinical and clinical development.

This work aligns with increasing regulatory focus on mRNA-LNP products as quality-critical systems, where lipid composition, impurity profiles, charge heterogeneity, encapsulation efficiency, and stability must be thoroughly understood and controlled.

Stronger Analytics for Complex LNP Systems

A common challenge in mRNA-LNP programs is that analytical methods often perform well in early development but fail during validation, stability studies, or technology transfer. This is particularly the case when critical attributes such as lipid composition, impurities, charge heterogeneity, or encapsulation efficiency are not sufficiently characterized from the outset.

nuvalore supports mRNA-LNP development programs with GMP-compliant, stability-indicating analytical methods, including:

• Imaged capillary isoelectric focusing (icIEF) for charge heterogeneity profiling
• Capillary electrophoresis (CE) for separation and identity analysis
• High-performance liquid chromatography with charged aerosol detection (HPLC-CAD) for lipid composition, quantitation, and impurity profiling

These approaches are applied across preclinical and clinical phases and are designed to align with Ph. Eur. and USP expectations for characterization, release, and stability.

Reliable Delivery Through Quality by Design (QbD)

nuvalore’s analytical strategies are designed to support robust performance under GMP conditions, with focus on:

• Robustness – Methods (icIEF, CE, HPLC-CAD) developed for routine QC use – not just one-off R&D applications
• Regulatory alignment – Approaches aligned with Ph. Eur. and USP expectations for characterization, release, and stability
• Stability-indicating insight – Detection of relevant degradation pathways through temperature stress, freeze–thaw robustness, and real-time stability studies

All methods are developed using a Quality by Design (QbD) approach, ensuring reliability across preclinical and clinical phases and supporting transfer into fully controlled GMP environments with reduced risk of rework.

Measuring mRNA-LNP Performance

nuvalore focuses on key quality attributes that drive mRNA-LNP performance and control:

• Lipid composition and quantitation (ionizable lipids, phospholipids, cholesterol, PEG-lipids) via HPLC-CAD
• Impurity profiling of LNP lipids and raw materials
• Charge heterogeneity and identity profiling using icIEF and CE
• Encapsulation efficiency and free vs. encapsulated mRNA
• Targeted LNP / conjugation analysis
• Stability-indicating studies supporting long-term control

These analytical strategies support the development of robust control frameworks for mRNA-LNP products throughout their lifecycle.

About nuvalore GmbH

nuvalore GmbH is a GMP-certified contract quality control laboratory based in Leimen, Baden-Württemberg, specializing in the analytical characterization of pharmaceuticals and biopharmaceuticals.

Founded in 2024, nuvalore supports clients with analytical method development, validation, and transfer, as well as Quality by Design (QbD)-driven approaches using Design of Experiments (DoE). Its capabilities include pharmacopoeial quality control, protein and surfactant analysis, ELISA, nanoparticle characterization, and testing of primary packaging and drug delivery systems.

Operating under a quality management system aligned with EU GMP and ICH guidelines, nuvalore supports pharmaceutical and biotechnology companies with reliable, regulatory-ready analytical data.

To learn more, visit:  https://nuvalore.com/en/

Resources

Schedule a discussion to compare analytical approaches and reduce mRNA-LNP method risk during stability and transfer.
Explore nuvalore services brochure.