The services are indispensable for validating and de-risking nucleic acid drugs. LNPs' function relies on controlled physical attributes, and comprehensive characterization ensures their stability, efficacy, and safety, with physical properties linked to biological fate per the literature.
Creative Biolabs turns LNP physical chemistry into verifiable CQAs, offering high-resolution data on Size, Charge, Morphology, and Crystallinity. It solves LNP development pain points, provides regulator-required robust datasets, and helps de-risk preclinical programs to accelerate regulatory filings.
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The drug delivery capability and therapeutic efficacy of lipid nanoparticles (LNPs) depend on the coordinated regulation of a series of their core properties—morphology, size and distribution, surface charge, phase transition temperature (PTT), and plasma protein interaction. These properties directly affect the drug-loading performance, biodistribution, and therapeutic safety of LNPs from key dimensions such as structural stability, delivery efficiency, and in vivo behavior.
Fig.1 The most relevant characterization techniques for LNs focus on parameters such as particle size (PS) and distribution, zeta potential (ZP), encapsulation efficiency (EE), loading capacity (LC), and physical stability.1
Creative Biolabs offers a modular suite of characterization services, allowing clients to select the specific data required to meet their phase-specific regulatory and quality needs.
| Particle Size Characterization Service | Utilizes Dynamic Light Scattering (DLS) and Nanoparticle Tracking Analysis (NTA) to precisely determine the mean size and Polydispersity Index (PDI), a CQA that correlates directly with systemic clearance and tissue distribution. |
| Morphology and Ultrastructure Characterization Service | Employs advanced Cryo-Transmission Electron Microscopy (Cryo-TEM) to provide visual confirmation of LNP structure, integrity, and homogeneity, which is essential for verifying proper drug encapsulation and preventing aggregate formation. |
| Surface Charge Characterization Service | Determines the Zeta Potential using Electrophoretic Light Scattering (ELS) to evaluate electrostatic stability, predict particle-cell interaction behavior, and confirm the pKa of ionizable lipids. |
| Crystallinity and Polymorphism Characterization Service | Leverages Differential Scanning Calorimetry (DSC) and X-ray Diffraction (XRD) to analyze the solid-state properties of the lipid components, which dictate long-term physical stability and payload release kinetics. |
| Co-existence of the Addition Colloidal Structure Characterization Service | Specialized analysis to detect and quantify non-functional colloidal structures (e.g., micelles, lipoplexes) that may co-exist with the intended LNP, ensuring purity and consistent performance. |
| Critical Quality Attribute Characterization Service | A modular package focusing on the most critical parameters (Size, PDI, Encapsulation Efficiency, Zeta Potential) required for standard Quality Control (QC) release testing and batch-to-batch consistency. |
| Physicochemical Stability Evaluation Service | Longitudinal studies under various stress conditions (temperature, agitation) to monitor changes in key CQAs over time, establishing robust shelf-life and storage recommendations. |
Our Custom Lipid Nanopartical-formulated Drug Characterization Services are designed to be a flexible, one-stop analytical solution for every stage of LNP development, from initial formulation screening to pre-clinical batch release. Creative Biolabs guarantees the precision and quality required to move your therapeutic forward.
Comprehensive Customization
Characterization projects are run in customized batch or continuous mode, ensuring the analytical strategy perfectly matches your unique LNP formulation (e.g., different lipid ratios, payload types, or target sizes).
End-to-End Analytical Support
We offer a one-stop characterization service ranging from initial method development and small-scale formulation stability checks to large-scale, high-throughput batch release testing.
Flexible Quality Systems
Our well-established quality system incorporates Quality-by-Design (QbD) principles for analytical method development, ensuring documentation and procedures are assessed and approved by a qualified quality assurance service before execution.
Guaranteed Formulation Stability Analysis
We provide specialized services to guarantee the structural stability of your LNPs from the bulk solution through various stress points (e.g., freeze/thaw, high temperature), focusing on critical attributes like size and morphology retention.
Advanced Analytical Toolset
We utilize a suite of high-standard quality control tools and process analytical techniques (PAT) to quantify, evaluate, and assure the quality of LNP products, including advanced thermal and microscopic analysis.
Regulatory Compliance Focus
All steps follow the basic principles of Good Manufacturing Practice (GMP) and utilize the Hazard Analysis Critical Control Point (HACCP) approach for critical process point identification in quality control.
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We focus on the critical link between physical LNP attributes and biological outcome. By precisely measuring Particle Size and Morphology, we confirm your formulation is optimized for the Enhanced Permeability and Retention (EPR) effect—essential for passive tumor targeting. Furthermore, validating Crystallinity and Surface Charge guarantees consistent payload release and structural integrity during circulation, minimizing systemic toxicity and maximizing efficacy.
DLS provides an average size, but it cannot differentiate between a high-quality, dense LNP and a flawed, empty particle, or a mixture of aggregates. Our Cryo-TEM and Ultrastructure Characterization Service provide direct, high-resolution visualization, confirming the internal integrity and homogeneity of your LNP structure. This visual proof is often a critical requirement during late-stage development and regulatory review.
Absolutely. All our assays are performed under strict quality management principles, and our reports are designed with the depth and detail required for regulatory filings. We employ orthogonal analytical techniques (e.g., using both DLS and NTA for size) to provide redundant, cross-validated data, delivering the high level of confidence regulators expect for novel drug delivery systems.
The duration typically ranges from 6 to 10 weeks, depending on the complexity of the formulation and the scope of the services selected. Projects requiring extensive Physicochemical Stability Evaluation will be longer. We prioritize communication and will provide a detailed, phase-gated timeline after our initial consultation.
Creative Biolabs provides comprehensive, high-resolution Custom Lipid Nanoparticle (LNP)-formulated Drug Characterization Services, critical for nucleic acid therapeutic development. Covering all Critical Quality Attributes (CQAs)—Size, Charge, Morphology, Stability—with unmatched analytical depth, we help clients de-risk programs, ensure product consistency, and speed up regulatory approval.
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