Nano Formulation Analysis and Verification

In the vast ocean of biomedical research and drug development, nanotechnology is like a bright beacon, leading an unprecedented path of innovation. It not only reshaped our understanding of disease treatment, but also profoundly changed the landscape of diagnostic strategy. As a leading biopharmaceutical company, BOC Sciences is committed to providing superior nano formulation analysis and validation services to meet the increasingly complex scientific exploration needs of the pharmaceutical and biotechnology industries.

Advantages of nano formulation analysis

Quality assurance: Ensuring the uniformity and stability of the nano formula is the cornerstone of maintaining product quality. Even the smallest variable can affect the efficacy and safety of the entire preparation.

Regulatory compliance: In the face of stringent standards from regulators, detailed data on the properties and performance of nanoformulations is required. Accurate analysis and verification is a solid bridge to cross the threshold of regulations.

Optimization and innovation: With in-depth analysis, we can identify and eliminate potential problems in the early stages of development, paving the way for continuous optimization of formulations.

Equal emphasis on safety and efficacy: The verification of the behavior and characteristics of nanomaterials is the key to ensuring the performance of drugs in biological systems, and plays a decisive role in patient safety and therapeutic effects.

Our nano formulation analysis and verification services

In the field of biomedicine, we know that every innovation of nano preparations carries the infinite vision of future medical treatment. We strive to create a full range of nanomaterials analysis and verification services, covering lipid nanoparticles, polymer nanoparticles, nanoemulsion, nanogel, nanocrystal, nanobody drug delivery and other diversified nanomaterials, using cutting-edge technology to provide in-depth analysis and scientific verification of your scientific research results.

Comprehensive characterization of nano formulations

• Particle size and polydispersity

We use cutting-edge technologies such as dynamic light scattering (DLS) and transmission electron microscopy (TEM) to accurately determine the particle size and polydispersion coefficient (PDI) of nanoparticles to ensure the uniformity and stability of the preparation and lay a solid foundation for the efficient delivery of drugs. SAXS uses X-ray scattering to study the structure of nanomaterials and to infer the size and distribution of nanoparticles by measuring the relationship between the scattering intensity and the scattering Angle. Different from the results of traditional particle size analyzer, SEM and TEM, the particle size analysis results of SAXS test reflect neither grains nor aggregates, but the size of primary particles.

Fig. 1 TME micro-mophylogy of nanoemulsion.

• Zeta potential and surface characteristics

The determination of zeta potential, like a probe, reveals the surface charge state of the nanoparticle in depth, which is crucial for predicting the stability of the nanoparticle in vivo environment and its interaction with the biofilm. We use advanced zeta potential analyzers to provide you with accurate data and powerful guidance for formulation optimization.

• Structural analysis and chemical characterization

X-ray diffraction (XRD) technology, like a pair of fluoroscopic eyes, analyzes the crystal structure of nanoparticles and reveals their internal secrets. The combination of infrared spectroscopy (FTIR) and Raman spectroscopy is like a translator of the chemical language, helping us to interpret the chemical bonds and functional groups in nanomaterials, ensuring the chemical integrity and functionality of the preparation.

• Encapsulation efficiency and drug load

With the help of modern analytical methods such as high performance liquid chromatography (HPLC) and UV-VIS spectroscopy, we accurately determine the encapsulation efficiency and drug loading capacity of drugs to ensure the efficient loading of drugs in nanocarriers, thereby greatly improving bioavailability and laying the foundation for accurate drug delivery and maximum efficacy.

• Drug release kinetics studies

We simulate the in vivo environment, delve into drug release dynamics, and evaluate the drug release patterns of nanoagents under different conditions to provide scientific basis for targeted delivery and controlled release design to ensure maximum drug effectiveness at the right time and place.

• Biological evaluation and safety testing

Biological evaluation is a key step in the analysis of nanomaterials, involving multiple dimensions such as cytotoxicity analysis, cell uptake studies and blood compatibility testing. We evaluated the cell viability after treatment by MTT assay and other cell viability assays to ensure the safety of the preparation. Fluorescence microscopy and flow cytometry were used to investigate the internalization and intracellular distribution of nanoparticles and reveal their biological distribution characteristics. The blood compatibility test ensures the non-hemolytic and blood compatibility of the formula and removes obstacles for human application.

• Endotoxin and sterility control of nanomedicine for injection

Determination of endotoxin includes color, turbidity and gel detection. Common interferences include colored nanomaterials that interfere with fluorescence measurements, nanosuspensions that interfere with turbidity measurements, and nanoparticles filtered with cellulose filters that produce false positives. When one LAL method is used to determine interference, another method should be considered.

• Stability test

Stability testing is the lifeline of nanomaterials development. We offer a comprehensive range of services, including accelerated stability testing, which predicts the shelf life of nanoformulations by exposing them to pressure conditions such as temperature, humidity and light, and long-term stability testing, which ensures the stability and effectiveness of the formulation through long-term monitoring, and protects your scientific research results.

Customized services and solutions

BOC Sciences provides customized analysis services and work closely with you to design personalized analysis solutions tailored to your specific goals. Whether it is the initial phase of formulation development, or the deepening of preclinical research, we will work with you to provide professional support to help your project proceed smoothly.

Data interpretation and reporting

Our analytical reports go beyond simple data aggregation to incorporate in-depth scientific insights and professional advice. Our team of experts will interpret each analysis for you, help you understand the science behind the data, guide subsequent formulation optimization and process improvement, and ensure that your research results bridge the gap between scientific rigor and clinical application.

Why choose BOC Sciences?

Excellent professional and technical team: Our team consists of a group of experienced scientists and engineers who not only have deep theoretical knowledge in the field of nanoagent analysis, but also have accumulated a wealth of practical experience. From particle size analysis to structural analysis, from thermal stability assessment to drug release kinetics studies, each member of our team is an expert in their field, dedicated to providing the most professional insights and guidance for your project.

Leading analytical technology and equipment: Our proud laboratories are equipped with the industry's most advanced analytical instruments, which are like magnifying glasses for scientific research, revealing the mysteries of the nanoworld.

• Nanometer particle size analyzer
• Transmission electron microscopy (TEM)
• Small angle X-ray scattering (SAXS)
• Laser Doppler velocimeter
• X-ray diffraction (XRD)
• High performance liquid chromatography (HPLC)
• Raman spectroscopy
• Differential scanning calorimetry (DSC)

Customized solutions: BOC Sciences offers highly customised services and work closely with you to understand your project objectives and design the analysis that best suits you.

Quality assurance and quick response: BOC Sciences is committed to strict quality control processes to ensure that your nanoformulations meet the highest international standards. From sample reception, analysis execution to results reporting, every step is carefully designed to ensure data accuracy and repeatability. At the same time, we understand the importance of time for scientific research projects, so we are committed to responding quickly to customer needs, providing timely services to help you shorten the research and development cycle and accelerate the transformation of results.

FAQ

1. What is nano formulation analysis and verification?

Nano formulation analysis and verification is a comprehensive service that includes a suite of tests and evaluations designed to ensure the quality, efficacy, and safety of nano drug delivery systems. This service involves physical and chemical characterization, biological evaluation, stability testing, and regulatory support.

2. What types of nano formulations do you analyze?

We analyze various types of nano formulations, including lipid nanoparticles, polymer nanoparticles, nanoemulsions, nanogels, nanocrystals, and nanobody drug delivery systems.

3. What methods do you use for physical characterization?

We use a range of advanced techniques for physical characterization, including dynamic light scattering (DLS), nanoparticle tracking analysis (NTA), transmission electron microscopy (TEM), scanning electron microscopy (SEM), X-ray diffraction (XRD), and differential scanning calorimetry (DSC).

4. How do you ensure the chemical composition of nano formulations?

We employ various spectroscopic and chromatographic methods such as Fourier-transform infrared spectroscopy (FTIR), nuclear magnetic resonance (NMR) spectroscopy, high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry to accurately identify and quantify the chemical components.

5. What biological evaluations do you perform?

Our biological evaluation includes in vitro cytotoxicity tests, cellular uptake studies using fluorescence microscopy and flow cytometry, and protein binding studies to understand the interaction of nanoparticles with biological systems.

6. How do you test the stability of nano formulations?

We conduct both accelerated stability testing, where formulations are exposed to stress conditions, and long-term stability testing, where formulations are monitored over extended periods to ensure they remain stable and effective.

7. How long does the analysis and verification process take?

The timeline for analysis and verification can vary depending on the complexity of the nano formulation and the specific tests required. Typically, the process can take from a few days to several months. We provide detailed timelines after evaluating your specific needs.

8. What makes your service unique?

Our service stands out due to our extensive expertise in nano formulation, state-of-the-art facilities, customized solutions tailored to your specific project needs, rigorous quality assurance processes, and deep regulatory knowledge.

9. Can you customize the analysis based on our specific requirements?

Absolutely. We work closely with our clients to understand their specific needs and customize our analysis and verification services accordingly to ensure optimal outcomes for their projects.

10. What kind of reports do you provide?

We provide comprehensive reports that include detailed data and analysis results, along with expert interpretations and recommendations to help you understand the performance and stability of your nano formulations.

11. How can we get started with your nano formulation analysis and verification services?

You can get started by contacting our customer service team or visiting our website. We will discuss your specific requirements, provide a detailed proposal, and guide you through the process of submitting your nano formulations for analysis and verification.

12. Do you offer ongoing support after the analysis is completed?

Yes, we offer ongoing support to address any follow-up questions or additional needs you may have after the initial analysis and verification are completed. Our goal is to ensure the long-term success of your nano formulations.