The demand for advanced nanoparticle therapies has surged in the rapidly developing fields of biotechnology and pharmaceuticals. Nanoparticles, including lipid nanoparticles (LNPs), gold nanoparticles, and other specialized nanomaterials, play a crucial role in drug delivery, diagnosis, and therapeutic applications. To meet this growing demand, we offer contract manufacturing services for nanoparticles to ensure the development, production, and quality control of these complex formulations.
Figure 1. Nanoparticle Contract Manufacturing.
Our Services
1. Research and Development (R&D)
Our nanoparticle contract R&D services are designed to support clients from early-stage research to preclinical development. We offer a comprehensive suite of tools and expertise to help clients optimize their nanoparticle formulations and evaluate their potential for clinical translation.
- Custom Synthesis and Product Development: We provide tailored synthesis of organic nano-electronic materials, functional polymers, and high-tech dyes, ensuring that the materials meet specific application requirements.
- Nanoparticle Fast Formulation Screening: Our team can rapidly screen various formulations to identify the most effective and stable nanoparticle systems for drug delivery.
- Bioconjugation Services: We specialize in the conjugation of antibodies, drugs, and other biomolecules to nanoparticles, enabling targeted drug delivery and enhanced therapeutic efficacy.
- Analytical and Characterization Services: We offer a range of analytical services, including dynamic light scattering (DLS), zeta potential measurement, and image analysis, to characterize nanoparticle properties and ensure consistency
Process Development and Optimization
Once a promising nanoparticle formulation is identified, the next step is to scale it up and optimize the manufacturing process. Our nanoparticle contract process development services are tailored to meet the unique needs of each client, whether they are in the early stages of development or preparing for commercialization.
- Formulation Optimization: We work closely with clients to optimize nanoparticle size, surface charge, and encapsulation efficiency, ensuring optimal drug loading and release profiles.
- Scale-Up Capabilities: Our facilities are equipped to handle both laboratory-scale and large-scale production, ensuring seamless transition from bench to production.
- Controlled Release Technologies: We offer expertise in the development of controlled-release nanoparticles, including those based on polymers like PLGA, which are ideal for sustained drug delivery.
- Lipid Nanoparticle (LNP) Formulation: We specialize in the formulation of lipid nanoparticles, which are widely used for delivering nucleic acids, proteins, and small molecules. Our services include LNP development, encapsulation, and quality control.
Manufacturing and Production
Our nanoparticle contract manufacturing services are designed to deliver high-quality, GMP-compliant products for both research and commercial applications. We adhere to strict regulatory standards and employ state-of-the-art equipment to ensure consistency and reproducibility.
- Aseptic Manufacturing: We provide aseptic manufacturing services for sensitive biological and lipid-based nanoparticles, ensuring sterility and safety.
- End-Point Sterile Filtration: Our facilities are equipped with advanced filtration systems to ensure the final product is free from contaminants and meets quality specifications.
- Facility Engineering Services: We offer facility engineering services to support clients in setting up or upgrading their manufacturing infrastructure, ensuring it meets the required standards for nanoparticle production.
- Cell Banking and Storage: For clients requiring cell-based nanoparticle formulations, we provide cell banking and storage services to maintain the integrity and viability of the cells.
Analytical Testing & Regulatory Support
Ensuring safety, efficacy, and compliance is critical in nanoparticle development. Our full-service analytical and regulatory support guarantees that your products meet industry standards. Our Testing Services Include:
| Key Materials | Descriptions |
|---|
| Physicochemical Characterization | Particle size (DLS), zeta potential, morphology (TEM/SEM), crystallinity (XRD). |
| Stability Studies | Accelerated and real-time stability testing under various conditions. |
| Regulatory Documentation | Preparation of CMC sections for FDA/EMA submissions, GMP compliance, and quality assurance. |
| Biological Testing | Cytotoxicity, hemocompatibility, in vitro/in vivo biodistribution. |
We work closely with clients to navigate regulatory pathways, ensuring a smooth transition from preclinical to clinical stages.
Quality Control and Regulatory Compliance
Quality control is a critical aspect of nanoparticle manufacturing, especially for therapeutic applications. We provide a comprehensive suite of analytical and quality control services to ensure that all products meet the highest standards of purity, stability, and safety.
- Microbial Quality Control: We conduct rigorous microbial testing to ensure that all products are free from contamination and meet regulatory requirements.
- Endotoxin Testing: We perform endotoxin testing to ensure that the final product is safe for use in biological systems.
- Regulatory Compliance: We help clients navigate the complex regulatory landscape, providing documentation and support.
Our Advantages
Global Reach and Collaboration
We collaborate with clients across the globe, offering customized solutions that meet the unique needs of each project.
Commitment to Quality
We are committed to delivering high-quality, innovative solutions that help clients bring their nanoparticle-based products to market faster and more efficiently.
Flexible Services
Whether you are in the early stages of development or preparing for commercialization, we offer flexible and scalable services to support your goals.
Workflow
Synthesis and Optimization
Summary
Nanoparticle contract manufacturing is a vital component of the modern pharmaceutical and biotechnology landscape. With our comprehensive suite of services, from R&D and process development to manufacturing and quality control, we are well-positioned to support clients in bringing their nanoparticle-based products to market. Whether you are developing a new drug delivery system, a diagnostic tool, or a therapeutic agent, we are here to help you succeed.
