Nanoparticle Contract Process Development

CD Bioparticles are experts in nanomaterial manufacturing at every stage of development, from concept validation to commercial manufacturing. Our team is always ready to support your project under a standard quality system, from design and expansion to full-scale production. With our profound expertise in the development of reproducible and scalable nanoparticles, we have a good track record in transferring novel nanomedicine platforms while maintaining their large-scale functionality. Talk to our experts immediately to learn how we can help you accelerate the development and commercialization of regulated products.

Figure 1. Nanoparticle Contract Process Development.

Unrivaled Technical Expertise

At our specialized service, we offer comprehensive nanoparticle contract process development solutions tailored to meet the unique needs of researchers and manufacturers in the biotechnology, pharmaceutical, and materials science sectors. Our expertise spans from early-stage research to large-scale production, ensuring that your nanoparticle formulations are optimized for purity, stability, and scalability. Below is a detailed overview of our services, organized under the four key headings.

Our Services

At CD Bioparticles, we specialize in nanoparticle contract process development, offering end-to-end solutions to optimize and scale your nanoparticle formulations. Our team of experts provides tailored strategies to ensure efficient, reproducible, and scalable production—from early-stage development to large-scale manufacturing.

TFF (Tangential Flow Filtration) Development Expertise – Providing a Scalable Pathway for Material Processing

Tangential Flow Filtration (TFF) is a critical step in nanoparticle purification and concentration. Our team has extensive experience in:

• Process optimization – Developing TFF protocols for efficient buffer exchange, concentration, and diafiltration.
• Scalability – Seamlessly transitioning from lab-scale (milliliters) to pilot and production-scale (hundreds of liters).
• Custom membrane selection – Choosing the optimal molecular weight cut-off (MWCO) and membrane material for your nanoparticle system.
• Robust performance – Ensuring high recovery yields while maintaining particle integrity and functionality.

Scaled Conjugation and Biofunctionalization – Proteins, Antibodies, Oligos, Peptides, and More

Precise surface modification is key to nanoparticle functionality. We offer:

• Controlled conjugation chemistry – Covalent and non-covalent attachment of ligands (e.g., antibodies, peptides, PEG, oligonucleotides).
• High-efficiency coupling – Optimizing reaction conditions (pH, temperature, stoichiometry) for maximum yield and minimal aggregation.
• Multi-step functionalization – Sequential modifications for complex targeting or stealth properties.
• Analytical validation – Confirming conjugation success via techniques such as HPLC, SDS-PAGE, DLS, and fluorescence labeling.

Fast In-Process Testing Available On-Site – Ensuring Quality at Every Step

Rapid analytical feedback accelerates development. Our in-house capabilities include:

• Endotoxin testing – Ensuring compliance with regulatory standards (<0.25 EU/mL for injectables).
• Size and morphology – Dynamic Light Scattering (DLS), Nanoparticle Tracking Analysis (NTA), TEM/SEM imaging.
• Colloidal stability – Zeta potential, aggregation assessment under physiological conditions.
• Concentration and purity – UV-Vis, BCA assay, SEC-HPLC.
• Custom assays – Development of application-specific quality control tests.

Development of Flow-Through and Batchwise Fabrication Techniques – Suited to Your Needs

We tailor nanoparticle synthesis to your scalability and throughput requirements:

• Flow-through (continuous) processes – Enabling high-throughput, consistent production with tight control over reaction kinetics.
• Batchwise fabrication – Optimized for small-scale R&D or large-scale GMP-compatible manufacturing.
• Hybrid approaches – Combining batch and continuous methods for complex multi-step formulations.

Characterization and Controls – Ensuring Your Specifications Are Met (mL to 100s of Liters)

Quality assurance is integral to our process. We provide:

• Comprehensive characterization – Physicochemical (size, PDI, zeta potential), biochemical (ligand density, binding efficiency), and functional (in vitro/in vivo performance).
• Stability studies – Real-time and accelerated testing under varying storage conditions.
• Batch-to-batch consistency – Rigorous QC protocols to meet regulatory and client specifications.
• Documentation support – Detailed reports for IND filings, tech transfer, and scale-up.

Solution

Whether your particles are classified as active pharmaceutical ingredients, drugs, excipients, or components, we provide manufacturing support and scale support from preclinical studies to phase I and II manufacturing. We have experience in developing nanoparticles for topical, oral, intravenous, subcutaneous and intranasal (spray) delivery routes. We are pleased to collaborate with your team to optimize materials, excipients, and buffer formulations based on your expected route of administration, utilizing interdisciplinary experience to maximize product efficacy. With end-to-end support, our team will help you accelerate development and commercialization goals.

Applications of Our Nanoparticle Process Development Services

Our Advantages

Workflow

Summary

In our nanoparticle contract process development services, we combine cutting-edge technology, professional knowledge, and a commitment to quality to provide excellent results. Whether you are developing new nanoparticle formulations, optimizing existing processes, or expanding production scale, we have the tools and expertise to support your journey from the laboratory to the market. Contact us immediately to learn more about how we can help you achieve your goals.