BOC Sciences is dedicated to advancing lipid nanoparticle (LNP) technology, offering comprehensive mRNA drug delivery solutions to global research institutions and biopharmaceutical companies. Our services encompass formulation development, optimization, analytical testing, and scale-up production, addressing critical challenges such as stability, efficiency, and targeting in mRNA drug delivery to accelerate drug development.
Needs Assessment: We work closely with clients to understand key parameters such as mRNA sequence, targeting requirements, and administration routes, defining clear project objectives.
Preliminary Formulation Design: Based on specific needs, we carefully select lipid components—including cationic lipids, neutral helper lipids, and cholesterol—determining mRNA loading, lipid ratios, and other essential parameters to create an initial formulation.
Small-Scale Preparation & Testing: Using techniques such as thin-film hydration and microfluidics, we prepare LNPs at a small scale in the lab and conduct preliminary testing to assess fundamental properties.
Performance Evaluation & Optimization: We thoroughly evaluate key characteristics such as particle size, encapsulation efficiency, and stability, continuously refining the formulation to enhance delivery performance.
In Vitro Validation: Optimized LNPs undergo in vitro studies to assess delivery efficiency, cellular uptake, and gene expression, ensuring optimal performance at the cellular level.
Process Optimization: We leverage advanced techniques such as microfluidics and high-pressure homogenization to precisely control temperature, pressure, and flow rates during production, maximizing mRNA encapsulation efficiency.
Material Selection: We carefully screen and select lipid components and excipients to enhance mRNA-lipid interactions and improve encapsulation.
Encapsulation Efficiency Testing & Optimization Cycle: Using high-performance liquid chromatography (HPLC) and other advanced analytical techniques, we accurately measure encapsulation efficiency and iteratively refine both the formulation and production process in a test-optimize-retest cycle until the desired efficiency is achieved.
Formulation Optimization: We improve LNP stability by adjusting lipid composition and incorporating stabilizers such as polyethylene glycol (PEG) to prevent aggregation and enhance storage and transport stability.
Storage Condition Research: Through systematic studies, we analyze the impact of temperature, humidity, and light exposure on LNP stability, determining optimal storage conditions and providing recommendations to extend shelf life.
Stability Monitoring & Improvement: We continuously monitor LNP stability during storage and transportation, tracking changes in particle size and encapsulation efficiency and implementing necessary corrective measures.
Targeting Needs Assessment: We collaborate with clients to define target tissues, cell types, and delivery efficiency requirements, setting clear delivery goals.
Surface Modification Strategy Design: Based on targeting requirements, we design LNP surface modifications by incorporating specific targeting ligands (e.g., antibodies, peptides, glycans) to enable precise receptor-mediated targeting.
Targeted LNP Preparation & Optimization: Using advanced techniques, we conjugate targeting ligands to LNP surfaces and optimize modification parameters to ensure high targeting specificity and delivery efficiency.
In Vitro & In Vivo Targeting Validation: We evaluate targeted LNP biodistribution, cellular uptake, and gene expression through cell-based assays and animal studies, refining surface modifications to maximize targeting efficiency.
Physical Characterization: We use cutting-edge instruments such as dynamic light scattering (DLS) and laser particle size analyzers to assess particle size distribution and zeta potential, ensuring optimal stability and delivery properties.
Chemical Analysis: High-performance liquid chromatography (HPLC) and mass spectrometry (MS) are employed to precisely analyze lipid composition and mRNA content, ensuring chemical accuracy and stability.
Biological Evaluation: Through in vitro cell studies and in vivo animal models, we systematically assess LNP delivery efficiency, cellular uptake, gene expression, and immunogenicity to ensure safety and efficacy.
Stability Testing: We conduct accelerated and long-term stability studies under various environmental conditions to monitor changes in physical, chemical, and biological properties, providing scientific data for storage and transport.
Process Scale-Up Design: Building on small-scale laboratory processes, we develop scalable manufacturing strategies for pilot and large-scale production, ensuring batch-to-batch consistency.
Equipment Selection & Validation: We select appropriate production equipment and conduct rigorous validation processes to ensure stable operation and compliance with large-scale manufacturing requirements.
Quality Control System Development: A comprehensive quality control system is implemented to monitor raw materials, intermediates, and final products, ensuring each batch meets stringent quality and safety standards.
GMP-Compliant Production: We strictly adhere to Good Manufacturing Practice (GMP) guidelines and operating procedures, ensuring regulatory compliance, batch traceability, and reliability for clinical applications and commercial deployment.
We begin by engaging in in-depth discussions to fully understand the project background, objectives, and specific requirements. This includes clarifying the characteristics of the mRNA drug and defining the expected delivery outcomes to ensure alignment with your goals.
Based on your requirements, we develop a detailed LNP formulation strategy. This includes selecting the most suitable lipids, optimizing process parameters, and establishing quality benchmarks to guide development.
Our team conducts small-scale LNP preparation in the lab, continuously refining both the formulation and process. We focus on optimizing particle characteristics, enhancing mRNA encapsulation efficiency, and improving overall stability.
We perform rigorous physical, chemical, and biological analyses to assess the performance and quality of the developed LNPs. Every formulation undergoes thorough testing to ensure it meets the expected standards for efficacy and safety.
Once optimized, the formulation is seamlessly transitioned to pilot or large-scale production. We implement strict quality control measures to maintain batch consistency and ensure product stability at every stage.
We deliver high-quality LNP products on time and provide continuous technical support. Whether for clinical research or market applications, we remain a trusted partner, offering expert consultation to support your success.
Capable of synthesizing and optimizing various lipid types, including ionizable lipids, phospholipids, cholesterol, and PEGylated lipids, ensuring effective mRNA encapsulation and stable delivery.
Used to assess key LNP parameters such as particle size, morphology, surface charge, encapsulation efficiency, and release properties, ensuring quality and performance.
Focused on exploring LNP applications in different therapeutic areas, such as infectious disease vaccines, cancer immunotherapy, and gene therapy. This platform optimizes LNP composition and structure for targeted delivery to specific cells or tissues, enhancing therapeutic efficacy and reducing side effects.
Capable of synthesizing high-quality mRNA with chemical modifications to improve stability and reduce immunogenicity, thereby enhancing therapeutic outcomes.
Expert TeamA highly experienced R&D team specializing in lipid nanoparticles and mRNA drug development, with extensive expertise and hands-on experience.
Customized SolutionsFlexible and tailored services designed to meet specific project requirements based on individual client needs.
Advanced Equipment & TechnologyEquipped with state-of-the-art R&D and production facilities, utilizing advanced manufacturing techniques to ensure high-quality, high-performance products.
Strict Quality ControlAdhering to rigorous GMP standards and quality management systems, with strict monitoring of each production stage to guarantee product safety and efficacy.
Rapid DeliveryOptimized processes to improve R&D and production efficiency, ensuring fast turnaround times for premium products and services.
LNPs effectively protect mRNA and facilitate its delivery to specific cells, enabling intracellular antigen protein expression and triggering immune responses. For example, Moderna and Pfizer-BioNTech;s COVID-19 mRNA vaccines (mRNA-1273 and BNT162b2) utilize LNP delivery systems. Researchers are also exploring LNP-based mRNA vaccines for other infectious diseases.
LNP-delivered mRNA can encode immune checkpoint inhibitors, co-stimulatory molecules, and other factors to enhance the body’s anti-tumor immune response. For example, LNPs incorporating mRNA encoding co-stimulatory receptors have shown promising results in cancer immunotherapy. Researchers are also developing tumor-targeted LNPs to enable mRNA expression specifically in cancer cells, inhibiting tumor growth or inducing apoptosis.
For genetic disorders caused by gene defects, such as hemophilia, LNPs can deliver mRNA encoding functional coagulation factors, enabling in vivo expression to restore function.
LNPs can deliver mRNA into cells to express missing or dysfunctional proteins, providing therapeutic benefits for various diseases.
LNP delivery systems are widely used to transport gene-editing tools (such as mRNA encoding CRISPR/Cas9 and associated guide RNAs) into target cells for precise genome modification.
By delivering specific transcription factor mRNAs, LNPs can induce cell reprogramming to differentiate into specific cell types, offering new sources of cells for regenerative medicine.
Researchers have developed LNPs capable of crossing the blood-brain barrier to deliver mRNA to neurons and astrocytes, offering potential treatments for various neurological disorders.
LNPs can serve as carriers for both imaging contrast agents and therapeutic drugs, enabling integrated disease diagnosis and treatment (theranostics). This application facilitates drug candidate screening in preclinical studies, patient selection in clinical trials, and personalized treatment strategies in clinical practice.
Our services provide support for numerous mRNA-based therapeutics including vaccine development, therapeutic protein production and gene editing tool applications. We design LNP delivery solutions to match specific mRNA sequences and functional needs using our broad experience and deep expertise.
The delivery efficiency of our lipids is significantly enhanced through meticulous optimization of their composition, particle size and surface properties. We perform thorough laboratory and living organism testing as part of our process to confirm that mRNA reaches intended cells and generates the necessary biological outcomes.
We maintain LNP stability and safety throughout formulation development by performing comprehensive stability evaluations and utilizing modification strategies like stabilizers and optimized storage conditions to extend shelf life.
Extending shelf life during formulation development requires performing comprehensive stability assessments alongside modification strategies such as stabilizer addition and storage condition optimization. The selection of low-immunogenic lipid materials and formulation optimization occurs through immunogenicity evaluation which helps reduce immune responses and maintain product safety.
We place great importance on developing lasting partnerships with our clients. We offer continual technical support and consulting after delivering your product to resolve any clinical research or market application technical issues and help resolve product quality concerns for your project's uninterrupted progress.
