Our professional lipid nanoparticle (LNP) business team offers clients high-quality LNP manufacturing services. Through advanced production methods and professional R&D expertise we can create lipid nanoparticles that meet your needs with precise particle sizes and both high stability and efficient encapsulation rates. Research projects related to drug delivery, gene therapy, or various biomedical fields receive reliable and efficient LNP solutions from our services which enhance research and product development.
Lipid Nanoparticle Formulation Development: Based on the specific characteristics of the drug molecules (such as molecular weight, solubility, stability, etc.), we design and optimize lipid nanoparticle formulations using advanced drug delivery system theories. This includes selecting suitable phospholipids, cholesterol, other auxiliary lipid materials, and drug loading methods (encapsulation or embedding) to achieve optimal drug encapsulation efficiency and stability.
For different administration routes (oral, injection, inhalation, etc.), we adjust the particle size, surface charge, and surface modification components of the lipid nanoparticles to ensure effective delivery of the drug to target tissues or cells in vivo. This also ensures appropriate circulation time, tissue distribution characteristics, and cellular uptake efficiency.
Lipid Nanoparticle Preparation Process Research: We offer a variety of screening and optimization services for lipid nanoparticle preparation techniques, such as membrane extrusion, high-pressure homogenization, microfluidic methods, and solvent injection. By systematically comparing the effects of different preparation methods on particle size distribution, morphological characteristics, encapsulation efficiency, drug release properties, and scalability, we help clients determine the optimal preparation process route.
We conduct research on key parameters in the preparation process, including temperature, pressure, flow rate, stirring speed, and the ratio of organic solvent to aqueous phase. This establishes a quantitative relationship between these parameters and the quality attributes of the lipid nanoparticles, enabling precise control of the preparation process and stable production.
Small-Batch Custom Manufacturing: We offer small-scale lipid nanoparticle custom manufacturing services for early-stage research, lead compound screening, and preliminary safety assessments. Adhering strictly to GMP (Good Manufacturing Practice) standards, we ensure compliance throughout the manufacturing process and consistency between product batches.
Based on client-provided formulations or those optimized by our R&D team, we perform small-batch production. Product specifications can be flexibly adjusted to meet specific customer requirements, ranging from a few grams to several kilograms. Detailed production batch reports and quality control data are provided, including particle size, zeta potential, encapsulation efficiency, drug content determination, and microbiological limit tests.
Pilot-Scale Production: When clients reach later-stage or prepare for larger-scale and market submissions, we offer pilot-scale production services. We address potential issues arising during the scale-up process from small to pilot scale, such as mixing uniformity, mass transfer and heat transfer efficiency changes, and equipment compatibility.
Production processes and equipment configurations are optimized according to commercial production quality and scale requirements. The best production process parameters and operating procedures are determined to ensure that the pilot-scale lipid nanoparticles maintain consistency in quality, performance, and stability with the small-scale products. This also provides reliable process validation data and technical support for subsequent commercial production.
Particle Size and Distribution Testing: Using advanced techniques such as Dynamic Light Scattering (DLS) and Nanoparticle Tracking Analysis (NTA), we accurately measure the particle size and distribution of lipid nanoparticles, monitor their stability under different storage conditions and over time, and detect any trends in particle size changes. This provides critical data for product quality control and stability studies.
Surface Potential Measurement: The surface potential of lipid nanoparticles is determined using Laser Doppler Electrophoresis technology, reflecting the surface charge characteristics of the nanoparticles. This is important for assessing the stability, interactions, and cellular uptake behavior of the nanoparticles in vivo. Surface potential data allows for optimization of the nanoparticle formulation, adjusting its surface charge to meet specific drug delivery requirements.
Morphology Analysis: Using high-resolution electron microscopy techniques such as Transmission Electron Microscopy (TEM) and Scanning Electron Microscopy (SEM), we observe the external morphology and internal structural features of lipid nanoparticles, such as sphericity, surface roughness, and membrane thickness. This provides insights into the physical state of the nanoparticles and the microscopic mechanisms of interaction with drugs, offering valuable morphological data for product development and quality evaluation.
Encapsulation Efficiency Measurement: Using separation techniques such as ultrafiltration centrifugation and Gel Permeation Chromatography (GPC), combined with analysis methods like High-Performance Liquid Chromatography (HPLC) and UV-Vis spectrophotometry, we accurately determine the encapsulation efficiency of drugs in lipid nanoparticles. This is the percentage of the actual drug encapsulated relative to the theoretical dose, which allows us to evaluate the ability of lipid nanoparticles to encapsulate the drug.
Drug Release Study: Simulating in vivo physiological environments (such as different pH values, temperatures, and the presence of enzymes), we use in vitro release systems such as dialysis, dynamic dialysis, and Franz diffusion cells to study the drug release kinetics from lipid nanoparticles. By establishing drug release curves, we analyze the release mechanisms (such as diffusion control, erosion control, or a combination of both) to provide scientific data for the design and optimization of drug delivery systems, ensuring the desired drug release profile and therapeutic effect.
We work closely with clients to understand their goals and recommend the best lipid nanoparticle formulation and process.
Our R&D team designs the formulation based on experiments and data analysis, optimizing lipid composition and preparation conditions.
In sterile environments, we use advanced equipment to precisely mix components, ensuring uniform and stable lipid nanoparticles.
Using techniques like DLS, Zeta analysis, and TEM, we thoroughly test particle size, charge, encapsulation efficiency, and purity to meet high standards.
We store products under optimal conditions (low temperature, light protection) and ensure safe, contamination-free delivery to clients.
We provide full support after delivery, including usage guidance, technical help, and ongoing quality monitoring.
Expert TeamOur skilled scientists and engineers ensure smooth project execution with their deep expertise in lipid nanoparticles.
Customized SolutionsWe tailor formulations and processes to client needs, including different nucleic acids (mRNA, siRNA, Cas9RNA) and target applications.
Advanced EquipmentWe use top-tier devices like microfluidic mixers and precision pumps to produce stable, uniform lipid nanoparticles, with capabilities from lab to large-scale production.
Strict Quality ControlWe tightly control every step - from raw materials to final testing - to deliver pure, active, contaminant-free products that meet regulatory standards.
One-Stop ServiceWe provide complete solutions from gene synthesis to lipid nanoparticle encapsulation, saving clients time and boosting R&D efficiency.
Fast R&D CycleOur optimized processes enable quick production, helping clients shorten development times and speed up market entry.
mRNA Delivery: Efficiently deliver mRNA into cells for protein expression, supporting cancer therapies, vaccines (e.g., COVID-19 mRNA vaccines), and other treatments.
Gene Therapy: Deliver CRISPR-Cas9 and other gene-editing tools to modify genes precisely, offering new options for treating genetic diseases and cancer.
Targeted Drug Delivery: Surface-modified lipid nanoparticles direct drugs to specific tissues or cells, improving therapeutic effects and reducing side effects.
Preventive Vaccines: Deliver mRNA targeting viruses and bacteria, supporting vaccine development for diseases like influenza, HIV, and COVID-19.
Cancer Vaccines: Encapsulate mRNA encoding tumor-specific antigens to create vaccines that stimulate the immune system to attack tumors.
Diagnostic Imaging: Serve as carriers for diagnostic agents to enhance imaging accuracy and sensitivity, aiding disease diagnosis.
Regenerative Medicine
Deliver growth factors, genes, or small molecules to support tissue repair, wound healing, cartilage regeneration, and organ restoration.
Cosmetics and Personal Care
Encapsulate active ingredients (e.g., vitamins, peptides, antioxidants) to boost skin penetration, stability, and effectiveness in anti-aging, moisturizing, and repair products.
Absolutely! We understand that each project has its unique research objectives and application context. Our professional team will work closely with you to fully understand your needs, including target sites, expected delivery effects, and more. We will design and optimize lipid nanoparticle formulations and preparation processes that are best suited for your project, ensuring that our services precisely meet your personalized requirements.
We have established a rigorous quality control system. From the procurement of raw materials, we carefully select and evaluate suppliers to ensure that all materials meet relevant standards. During production, we use advanced analytical instruments and techniques, such as dynamic light scattering (DLS) for particle size and size distribution analysis, and potential analysis for surface charge measurement, to comprehensively test the physicochemical properties of the lipid nanoparticles. Additionally, we strictly control key indicators such as purity, activity, and encapsulation rate to ensure that the lipid nanoparticles delivered to you are of high quality, high purity, and free of contamination, complying with relevant quality standards and regulatory requirements.
Yes, our lipid nanoparticles are specially designed and optimized to have excellent stability. By selecting the appropriate lipid components, adjusting formulation ratios, and using advanced preparation techniques, we ensure that the lipid nanoparticles maintain the stability of their physicochemical properties and structure over an extended period, thereby extending the product's shelf life. Additionally, we provide corresponding storage recommendations and stability testing data based on customer requirements to help you better preserve and use our products.
