Your partner from feasibility through manufacturing Nanoparticle CDMO Services
Develop, scale, and manufacture nanoparticles and microparticles for your application. Our nanoparticle CDMO services support programs from early feasibility to repeatable material supply.
Schedule a Consultation20+ YearsNanoparticle expertise
ISO 13485Certified quality system
Made in USASan Diego, California
Development & Manufacturing by Application
Application requirements shape particle design, performance targets, and manufacturing needs. Our development and manufacturing approach connects material design decisions to your performance requirements.
Nanomedicine
Advance particle-based therapeutics through formulation development, active loading, release control, surface chemistry, and process scale-up.
Optical Engineering
Tune composition, size, morphology, surface chemistry, and dispersion for target optical performance.
Dermatology & Aesthetics
Develop particle systems for advanced delivery and light-responsive applications.
Diagnostics
Develop and scale custom particle systems and conjugated reagents for diagnostic workflows.
Nanoparticle CDMO Services Built Around Your Program
We work with you to define a technical scope and performance goals based on where your program is today. Our R&D and Manufacturing Science & Technology (MSAT) teams collaborate across development, allowing process risks and scale-up considerations to be addressed early. Projects can range from focused feasibility studies to process development, scale-up, technology transfer, and custom manufacturing.
1. Feasibility
Translate application requirements into target specifications and screen candidate particle designs or conjugation approaches.
2. Optimization
Refine your particle around the attributes that drive performance in your application.
3. Process Development
Define the process and controls needed for scale-up, then use engineering work to establish repeatability before routine production.
4. Manufacturing
Produce custom material with the controls, testing, documentation, and supply planning appropriate to your program.
Designing for Scale from the Start
Our R&D and MSAT teams work together from the start, enabling early risk assessment and scalable unit operations evaluation. This early collaboration enables a more deliberate path from technical feasibility to repeatable manufacturing.
Characterize What Matters
Utilize project-specific measurements to compare designs, define specifications, troubleshoot processes, and assess reproducibility.
Size & MorphologyDLS, LDA, TEM, SEM, BET
Surface ChemistryZeta potential, FTIR, pH titration
Conjugation, Loading & ReleaseUV-Vis, fluorescence, HPLC, ELISA
Optical PropertiesUV-Vis, fluorescence, dark-field, reflectance
Composition & ConcentrationICP-MS, HPLC
Custom CharacterizationDeveloped for your application requirements
Quality Systems & Manufacturing Infrastructure
We align quality and manufacturing controls to your program requirements, from documentation and traceability through testing and production.
nanoComposix manufactures its products in San Diego, California. For applicable programs, our ISO 13485:2016-certified quality management system, FDA Drug Establishment Registration, and State of California Drug Manufacturing License support regulated manufacturing requirements.
Additional quality and GMP controls can be incorporated where appropriate as programs advance through development, scale-up, and manufacturing.
Discuss Your Nanoparticle Development or Manufacturing Project
Let's define the nanoparticle CDMO services your program needs, from a focused feasibility study to process transfer and ongoing custom supply.
Talk with Our Technical TeamCDMO Programs in Practice
Examples from prior collaborations include:
Nanomedicine
- Scaled a topical particle formulation from mg quantities to 0.5 kg while maintaining critical particle attributes.
- Used iterative development to align a silica-based particle platform with performance requirements across in vitro and in vivo testing.
- Optimized and scaled iron oxide nanoparticles with stringent size and magnetic requirements, supporting multiple batches for clinical trials.
Optical Engineering
- Developed multiple nanoparticle candidates for a VR materials program with targeted optical properties and early scale-up assessment.
- Identified, fabricated, and evaluated a specialized solar nanomaterial through prototype integration and scale-up planning.
- Produced silica spacer particles with controlled morphology and custom surface chemistry for display applications.
Diagnostics
- Developed a custom antibody-gold nanoshell conjugate for a point-of-care diagnostic requiring improved sensitivity and increased production scale.
- Supported a food safety assay with 80 nm colloidal gold and integration support to improve assay sensitivity and advance commercialization.
- Produced streptavidin gold conjugates that eliminated false positives observed with in-house conjugates and supported product launch.
FAQs: Nanoparticle CDMO Services
Can a project start from an existing nanoComposix material?
Yes. Catalog nanoparticles and magnetic bead platforms can provide a characterized starting point for custom size, surface, conjugation, concentration, solvent, or other modifications. Projects can also begin with a fully custom material.
Can you transfer a process we already developed?
Yes. We can work from your existing specifications, protocol, analytical methods, and known process sensitivities to establish the process in our manufacturing environment. Depending on the program, the transfer may include process adaptation, raw material and equipment qualification, engineering runs, documentation, and testing.
Can you develop conjugated or functionalized particles?
Yes. We support a range of conjugation strategies, including covalent approaches such as EDC/sulfo-NHS, click chemistry, and thiol coupling. Affinity-based approaches including streptavidin-biotin, Protein A, and Protein G are also available. These chemistries can be used to functionalize particles with antibodies, enzymes, nucleic acids, peptides, and other biomolecules. Explore custom conjugate development and manufacturing.
How is characterization handled for a custom project?
Characterization is selected around the material and the decision the data needs to support. Project scopes may include particle attributes, chemistry, conjugation, loading, stability, release, functional performance, and reproducibility. Standardized standalone testing is also available through our catalog characterization services.
Do all projects require the same quality or GMP controls?
No. The quality approach should reflect the intended application and development stage. Discuss documentation, traceability, testing, release requirements, and manufacturing controls during scoping so the program is built around the requirements that actually apply.