At BOC Sciences, as a professional lipid nanoparticle team, we are committed to providing you with outstanding lipid nanoparticle stability services. With advanced laboratory equipment and a professional technical team, we are capable of accurately assessing the stability of lipid nanoparticles, analyzing their performance under various environmental conditions, and providing key data support for your product research, production, and storage. This helps you create more reliable and efficient lipid nanoparticle products, enhancing their competitiveness in the market.
Long-Term Stability Study: Following ICH conditions or customer-specific requirements, lipid nanoparticle samples are stored for long periods and periodically tested to evaluate their physical and chemical stability at different time points, such as changes in particle size, encapsulation efficiency, drug release characteristics, etc., to determine their shelf life.
Accelerated Stability Testing: Lipid nanoparticles are exposed to higher-than-normal storage conditions, such as temperature and humidity, to observe changes in their stability under accelerated conditions. This helps predict the stability trend of the product during long-term storage, saving customers time and costs.
Freeze-Thaw Stability Study: For lipid nanoparticles requiring freezing storage, multiple freeze-thaw cycles are conducted to detect changes in particle size distribution, appearance, activity, etc., during the freezing and thawing process. This helps assess the impact of freeze-thaw cycles on stability and provides a basis for product transport and storage.
Lipid Component Screening and Optimization: Based on customer needs and intended applications, we screen and match various ionizable lipids, neutral lipids, phospholipids, and other components to optimize the composition of lipid nanoparticles. This improves their stability, encapsulation efficiency, cell uptake efficiency, and other performance characteristics.
Particle Size and Surface Charge Control: By adjusting preparation process parameters and formulation composition, we precisely control the particle size and distribution of lipid nanoparticles, as well as their surface charge. This enhances their stability and biocompatibility in physiological environments and is beneficial for prolonging their circulation time in vivo.
Encapsulation Efficiency Enhancement: Using advanced preparation techniques and optimized formulations, we improve the encapsulation efficiency of active ingredients within lipid nanoparticles, reduce drug leakage during preparation and storage, and enhance the stability and therapeutic efficacy of lipid nanoparticles.
Physicochemical Characterization: Using a variety of high-precision analytical instruments, such as dynamic light scattering, transmission electron microscopy, laser particle size analyzers, and potentiometers, we conduct detailed physicochemical characterization of lipid nanoparticles, including particle size distribution, morphology, zeta potential, and chemical composition. This provides fundamental data for stability evaluation and formulation optimization.
Encapsulation Efficiency and Drug Loading Determination: Using high-performance liquid chromatography, UV-Visible spectrophotometry, and other methods, we accurately measure the encapsulation efficiency and drug loading capacity of lipid nanoparticles. This helps assess their ability to load active ingredients and provides important information for the effectiveness of drug delivery systems.
Drug Release Characteristics Analysis: In vitro studies are conducted under simulated physiological conditions to analyze the drug release rate and mechanism of lipid nanoparticles. This allows us to understand their potential therapeutic effects in vivo while also monitoring changes in particle stability during the release process.
Lab-Scale Production and Process Optimization: At the laboratory scale, we conduct small-scale production of lipid nanoparticles using optimized formulations and process parameters. Key process parameters during production are monitored and optimized to ensure product quality stability and batch-to-batch consistency, laying the foundation for subsequent large-scale production.
Pilot Scale-Up and GMP Production: We have the capability for pilot scale-up and GMP production, smoothly scaling up the small-scale process to pilot and large-scale production. This ensures the quality stability and control of lipid nanoparticles at different production scales, meeting the demands of clinical research and commercial production.
Personalized Formulation Development: Based on the specific needs of clients, such as drug type, therapeutic targets, and administration routes, we offer personalized lipid nanoparticle formulation development services to create customized drug delivery systems.
Specialized Customization: In addition to conventional formulation and process services, we offer customized R&D and production services based on clients' specific needs, such as developing lipid nanoparticles with particular functions, designing multi-target delivery systems, or achieving stimulus-responsive drug release, to meet clients' differentiated needs in innovative drug development.
Assessing LNP stability in the presence of drugs, nucleic acids, or other bioactive compounds.
Compatibility testing with delivery systems or co-formulations (e.g., mRNA or siRNA).
Use of predictive modeling to estimate LNP stability under various conditions.
Custom stability projections based on experimental data and client-specific needs.
Clients share nanoparticle details and evaluation needs; we assess feasibility and propose a tailored plan and quote.
After agreement, we sign a contract; clients prepare and send samples with background information for testing.
Our lab conducts comprehensive stability testing using advanced equipment, covering particle size, zeta potential, drug release, lipid oxidation, and more.
We analyze test data, identify stability trends and factors, and deliver a detailed report with methods, results, conclusions, and improvement suggestions.
After internal review, we deliver the report and communicate with the client to ensure understanding and address any questions.
We stay in touch for feedback and can provide additional technical support or solutions based on client needs.
Professional TeamOur expert team from nanotechnology, drug delivery, and biochemistry deeply understands factors affecting lipid nanoparticle stability, delivering professional solutions.
Advanced Equipment and TechnologyUsing top instruments like dynamic light scattering and differential scanning calorimetry, we accurately measure particle size, zeta potential, and thermal stability.
Comprehensive Stability EvaluationWe provide full-scale testing-physical, chemical, and biological stability-under short-term, long-term, accelerated, and real-time conditions.
Customized ServicesWe tailor stability plans to client needs, ensuring precise, practical evaluation for drug delivery, cosmetics, and biopharmaceuticals.
Fast and Efficient Testing CycleStrict Quality ControlOur service covers a comprehensive evaluation of the stability of lipid nanoparticles under different environmental conditions, including physical stability such as particle size changes and aggregation, chemical stability such as oxidation, hydrolysis, and other degradation reactions, as well as biological stability such as release and degradation in biological media. Additionally, we offer customized stability testing plans based on client needs to meet the requirements of various research and applications.
Certainly. We have advanced analytical technologies and a professional technical team that can perform in-depth stability analysis on various lipid nanoparticle components, such as ionizable cationic lipids, auxiliary lipids, PEGylated lipids, etc., and different structural designs. This helps you understand their stability and potential stability issues under specific conditions.
We use a variety of advanced techniques, including Dynamic Light Scattering (DLS) to measure particle size and its distribution, assessing particle aggregation stability; Nanoparticle Tracking Analysis (NTA) for direct observation and analysis of individual nanoparticles, providing more accurate particle size and concentration measurements; Differential Scanning Calorimetry (DSC) to study the thermal stability of lipid nanoparticles and detect thermodynamic parameters such as phase transition temperature; and High-Performance Liquid Chromatography (HPLC) to analyze lipid component degradation and assess chemical stability.
