LNP Characterization & Stability Testing
Overview
Our LNP Characterization & Stability Testing service delivers rigorous physicochemical and stability data under ICH and client-defined protocols, enabling IND-enabling packages for mRNA, siRNA, and other nucleic acid payloads.
Lipid nanoparticles (LNPs) are complex drug delivery systems whose performance relies on maintaining particle size, encapsulation integrity, and drug release characteristics over time. Our service evaluates both long-term storage stability and accelerated stress conditions, providing the comprehensive data needed for regulatory submissions and commercial readiness.
From single-batch characterization to multi-condition stability programs, our team executes study designs tailored to each formulation. Periodic sampling and analysis track critical quality attributes (CQAs) — particle size, polydispersity index (PDI), zeta potential, encapsulation efficiency, and release kinetics — enabling data-driven shelf-life projections.
Key Features
Long-Term Stability Storage
Samples are stored under specified ICH or client-defined conditions (e.g., 2–8°C, 25°C / 60% RH) for extended periods. At pre-defined intervals, aliquots are withdrawn for measurement of particle size, PDI, zeta potential, encapsulation efficiency, and drug release. The resulting time-course data is used to determine shelf life and identify degradation trends.
Accelerated Stability Studies
Elevated temperature and humidity conditions (e.g., 40°C / 75% RH) are applied to accelerate degradation and predict long-term stability in a compressed timeline. Periodic sampling quantifies changes in CQAs, enabling early risk assessment and formulation optimization before committing to full-length studies.
Study Modalities
Our stability testing platform accommodates a wide range of LNP formulations and nucleic acid cargoes.
- mRNA-LNP Formulations: Monitor mRNA integrity, encapsulation efficiency, and particle stability over time under storage and stress conditions.
- siRNA / saRNA-LNP Formulations: Evaluate small RNA payload retention, lipid degradation, and aggregation propensity in long-term and accelerated protocols.
Workflow
Each stability study follows a structured yet customizable process to ensure data integrity and alignment with regulatory expectations.
- Study Design & Sample Receipt: Upon receipt, we conduct initial characterization (size, PDI, zeta potential, EE) and assign storage conditions per ICH Q1A(R2) or client-specified protocols. A sampling schedule and stability chamber conditions are documented in the study plan.
- Stability Storage & Periodic Sampling: Formulation aliquots are placed at designated long-term and/or accelerated conditions. At each time point (e.g., 0, 1, 3, 6 months), representative samples are withdrawn for analysis.
- Analytical Testing & Data Review: Each sample is assayed for particle size, PDI, zeta potential, encapsulation efficiency, and drug release (in vitro release profile). All data undergo peer review and are tracked in controlled laboratory databases.
Custom Protocol Integration
Studies can incorporate client-specific storage conditions, additional time points, or secondary assays (e.g., endotoxin, osmolality, appearance). We adapt the protocol to the formulation's stage of development and regulatory target.
Quality Assurance
All stability testing is performed in our analytical laboratories following controlled, documented procedures. Instruments (DLS, HPLC, zeta potential analyzers) are calibrated and maintained per a recurring schedule. Data is captured electronically with audit trails to support regulatory inspection readiness.
Our reports include raw data, trend analysis, and a clear shelf-life recommendation based on the stability study results. When requested, summary data can be formatted for inclusion in IND or CTA submission modules.
Why Choose Us
- Regulatory-Focused Study Design: Protocols are designed with ICH Q1A(R2) and regional guidelines in mind, supporting IND and clinical trial applications.
- Comprehensive Analytical Panel: A full suite of orthogonal assays — DLS, HPLC, UV-Vis, and in vitro release — captures all critical quality attributes.
- Flexible Project Scope: Storage conditions, time points, and additional testing (e.g., morphology, flocculation) are defined per project, not forced into fixed packages.
- Experienced Scientific Team: Our scientists have extensive hands-on experience with lipid nanoformulations, from early discovery to late-stage development.
- Backed by Creative Biogene: All projects are delivered under Creative Biogene's ISO-aligned quality system, with dedicated project management, milestone-based reporting, and full intellectual property protection for your data.
LNP Types Tested
Our stability platform is compatible with a wide range of LNP compositions and cargo types.
- mRNA-LNP Formulations (linear, circular, and self-amplifying): Both research-grade and GMP-like formulations; payload integrity monitored alongside particle stability.
- siRNA / saRNA-LNP Formulations: Small RNA formulations evaluated for encapsulation retention and aggregation risk under stress.
Whether you are screening carriers, refining lead candidates, or building a regulatory package, the scientific team at Creative Biogene can help you design the right experimental strategy—from formulation and assay selection to data interpretation. Reach out to discuss a tailored solution for your next project.
