Lipid Nanoparticle (LNP) Development Services

In the rapidly evolving biopharmaceutical sector, precise and efficient therapeutic delivery systems have become a core element driving industry innovation. At BOC Sciences, we focus on developing innovative drug formulations, with a particular focus on lipid nanoparticles (LNPs). Our comprehensive lipid nanoparticle development services are designed to provide customized solutions to meet the unique needs of our customers, from early stage development to mass production.

What are lipid nanoparticles?

Lipid nanoparticle is a stable nanoparticle composed of functional lipids, PEGylated lipids, saturated phospholipids (DSPCS), and cholesterol. Functional lipids are ionizable cationic liposomes that play a key role in cell penetration and release. In earlier designs, cationic liposomes were permanently charged and could effectively bind to cell membranes and oligonucleotide apis, but their cytotoxicity limited their long-term use in LNP designs. Ionizable cationic liposomes show better pH sensitivity: neutral pH can protect LNP structural integrity and reduce toxic side effects. Ionizable cationic liposomes are central to the successful development of LNP.

Fig. 1 Simplistic illustration of LNP and its individual components. The LNP can encapsulate many nucleic acid cargo types including but not limited to DNA, ASOs, siRNA, microRNA, and mRNA. (Albertsen, C. H., 2022)

What are the benefits of lipid nanoparticles?

Improved bioavailability: LNPs achieves better delivery and absorption efficiency by enhancing the solubility and stability of less water-soluble drugs.

Targeted delivery enhancement: Well-designed LNPs can precisely target specific cells or tissues, significantly reducing untargeted side effects and optimizing the therapeutic window.

Highly adaptable: Whether small molecules, peptides, proteins, or nucleic acids, LNPs can be used as ideal vectors, showing excellent versatility and suitable for a variety of therapies.

Controlled release mechanism: Relying on the diffusion or degradation of the lipid matrix, LNPs can achieve the on-demand release of the payload and improve the therapeutic effect.

Biocompatibility and degradability: Due to the composition of biocompatible lipids, LNPs show excellent human tolerance, and the metabolites are harmless, which greatly reduces the potential adverse reactions.

Types of lipid nanoparticles

Solid lipid nanoparticles (SLNs): SLNs are composed of solid lipids with a solid core matrix that can bind hydrophobic and hydrophilic drugs. They offer advantages in terms of physical stability and drug release control.

Nanostructured lipid carriers (NLCs): In contrast to SLNS, NLCs contain a mixture of solid and liquid lipids. This combination resulted in a less ordered structure that could encapsulate more drugs and allow for improved drug release profiles.

Lipid-polymer hybrid nanoparticles (LPNS): They consist of a lipid shell and a polymer core, and vice versa. lpn combines the benefits of lipid systems and polymer nanoparticles, including stability, controlled release, and targeted delivery.

Long-circulating lipid nanoparticles: These are designed to evade detection by the human immune system, allowing for extended circulation time and improved targeting of diseased tissue.

Lipid drug conjugate (LDC): A new compound formed by lipophilic modification of water-soluble or insoluble drugs. Improve drug absorption and efficacy, suitable for water-soluble drugs and compounds that are difficult to develop.

What are the applications of lipid nanoparticles?

Vaccine development: In the era of epidemics, lipid nanoparticles have become a key ingredient in mRNA vaccine formulations, as exemplified by the success of the COVID-19 vaccine. These nanoparticles promote efficient uptake by cells, ensure translation of viral antigens, and promote a robust immune response.

mRNA therapy: The versatility of lipid nanoparticles makes them invaluable in the field of MRNa-based therapies. These nanoparticles are able to target and control the delivery of genetic material and are expected to be used to treat a variety of diseases, including cancer. We are committed to advancing mRNA therapies, partnering with researchers and pharmaceutical companies to advance precision medicine.

Gene delivery: Lipid nanoparticles play a key role in improving the efficiency of gene delivery, opening up new areas for gene editing and personalized medicine. Their ability to encapsulate and protect genetic material makes them indispensable.

Drug delivery: Tailored lipid nanoparticles provide a sophisticated platform for precise drug delivery. These nanoparticles improve the bioavailability of drugs, minimize side effects, and open avenues for the development of new therapies with improved therapeutic outcomes. From traditional drug delivery to innovative treatment strategies, nanotechnology innovation remains a key player in shaping the future of healthcare solutions.

Our lipid nanoparticle development service process

• Customer demand analysis
• Nanoparticle formulation design
• Fine preparation and optimization of lipid nanoparticles
• Quality control
• Bioefficacy assessment
• Stability investigation
• Process extension and validation
• Detailed reporting and technical support

Our detailed lipid nanoparticle development services include:

Development of customized formulation of lipid nanoparticles

At BOC Sciences, we have assembled an elite team of senior scientists and leading edge researchers dedicated to working with our clients to tailor LNP formulations to their specific needs. Whether it is the encapsulation of mRNA, siRNA, CRISPR/Cas9 components or other therapeutic agents, we use the most advanced technologies and innovative strategies to achieve optimal packaging efficiency and biological performance, ensuring that customers receive tailor-made solutions.

Preparation of lipid nanoparticles

Automated microfluidic mixing equipment or microfluidic chip is a fast and efficient way to prepare LNPs. These devices can be quickly blended in a highly controlled, repeatable manner, resulting in uniform LNPs and high package efficiency. Using cutting-edge microfluidic technology or ultrasonic processing, we can accurately prepare LNP with uniform particle size, ensuring its stability and biological distribution during delivery in vivo. In addition, in order to meet the needs of long-term storage and convenient transportation, we also provide freeze-drying services to ensure that LNPs can be quickly restored to the ideal state before use, so as to facilitate immediate application.

In-depth characterization of lipid nanoparticles

With a range of high-precision analytical instruments, we perform comprehensive and detailed physical and chemical characterization of liposome nanoparticles. This includes particle size distribution analysis, zeta potential determination, chemical composition analysis, and morphological observation to ensure that each batch of LNP meets strict quality standards, laying a solid foundation for subsequent biological evaluation and clinical application.

BOC Sciences is committed to upholding the highest standards, whether in formulation development, preparation process or quality control, to provide our customers with impeccable professional services, and jointly explore the unlimited potential of LNP technology to bring benefits to patients around the world.

Advantages of our lipid nanoparticle development services

Expert team: Bring together senior pharmaceutical scientists and biomedical engineering experts, with solid theoretical foundation and rich practical experience.

Cutting-edge technology: The adoption of international cutting-edge preparation technology and analytical instruments to ensure excellent quality and efficient output of lipid nanoparticles. Cutting-edge technology: The adoption of international cutting-edge preparation technology and analytical instruments to ensure excellent quality and efficient output of lipid nanoparticles. Includes:

• High pressure homogenizer
• Ultrasonic processor
• Microfluidic devices
• Dynamic light scatterer (DLS)
• Transmission electron microscope (TEM)
• bioreactor

Personalized service: Based on the specific needs of customers, we provide a full chain customization strategy from formula design to process expansion.

Strict quality control: comply with GMP standards to ensure that the quality of each batch of lipid nanoparticles is controllable and meets the standards of preclinical and clinical trials.

Agile response: Build efficient operation processes, reduce research and development cycles, and accelerate the pace of drug market.

FAQ

1. What are lipid nanoparticles?

Lipid nanoparticles are tiny spherical carriers made of lipids, designed to encapsulate and deliver therapeutic agents, such as nucleic acids, small molecules, or proteins, to specific cells or tissues in the body.

2. What applications are LNPs suitable for?

LNPs are extensively used in drug delivery systems, particularly for gene therapies, mRNA vaccines, cancer treatments, and in the development of siRNA, mRNA, and DNA-based therapeutics.

3. Why should I choose your LNP development services?

Our company offers comprehensive LNP development services including formulation optimization, scale-up production, characterization, and stability testing.

Our team consists of experienced scientists employing state-of-the-art technology to ensure the effectiveness and safety of your therapeutic agents.

4. Can you help with the formulation of custom LNPs for my specific therapeutic?

Absolutely. We specialize in custom formulations tailored to meet the specific needs of your therapeutic agents, ensuring optimal delivery efficiency and stability.

5. What steps are involved in your LNP development process?

• Initial consultation and project planning
• Lipid screening and selection
• Formulation development and optimization
• Characterization (particle size, encapsulation efficiency, zeta potential)
• In vitro and in vivo testing
• Scale-up production and stability testing

6. How do you ensure the quality and reproducibility of your LNP formulations?

Quality and reproducibility are ensured through rigorous analytical methods, including dynamic light scattering (DLS) for particle size analysis, encapsulation efficiency assays, electron microscopy, and stability studies. We also follow good manufacturing practices (GMP) for production.

7. How long does the LNP development process typically take?

The development timeline can vary depending on the complexity of the project. Typically, a standard LNP development project may take anywhere from a few weeks to several months from initial formulation development to final product stability testing.

8. What kind of post-development support do you provide?

Post-development, we offer continuous support including troubleshooting, additional scaling, and tech transfer to your manufacturing facility. We also provide ongoing stability studies and reformulation services as needed.