nanoComposix: Your Partner for Nanoparticle Formulation
Enabling Nanomedicine Innovations
Leverage our expertise in custom polymer, silica, and metal nanoparticle formulations to transform your innovations into next-generation therapeutics and diagnostics.
26
Pre-Clinical Development Programs
50
GMP Batches
Built for Teams Like Yours
For pharma and biotech research teams, nanoparticle-based programs introduce unique roadblocks across the product lifecycle. Accelerate your development efforts by partnering with experienced nanoparticle formulation experts at nanoComposix.
Supporting early nanoparticle design and optimization.
Clarity at the Feasibility Stage
A biopharmaceutical developer evaluating mesoporous silica for API loading needed to identify viable particle designs quickly. Screening across particle types and capping strategies optimized loading, release, and stability, enabling selection of a pre-clinical formulation.
Supporting translation from bench-scale formulations to scalable processes.
PLGA Nanoparticles for Immunotherapy
To enable an API delivery platform with precise particle size, release, and stability requirements, we designed the formulation, built a scalable process, and delivered GMP-grade material for Phase I and II trials.
Supporting alignment with clinical and regulatory specifications.
GMP Transfer of a Topical Photothermal Therapeutic
A customer with an acne treatment already on the market came to us needing a second GMP-qualified source. We delivered commercial GMP batches that were indistinguishable from the original manufacturer’s.
What’s Limiting Your Nanoparticle Development
The unique properties of nanoparticles introduce development, scale-up, and manufacturing challenges that exceed conventional formulation approaches.
Limited Nanoparticle Formulation Expertise
Specialized nanoparticle platforms often require multidisciplinary expertise that extends beyond conventional formulation development.
Scale-Up Bottlenecks
Bench-scale processes do not always translate directly to production scale, as nanoparticle fabrication requires material-specific control of multiple interdependent parameters.
Narrow Nanoparticle Focus
Nanoparticle development experience is often concentrated in a limited set of platform types, leaving gaps in support for alternative materials such as metals, silica, or polymers.
Rigid Processes with Limited Flexibility
Conventional development processes can limit flexibility, sometimes requiring teams to adapt their formulations rather than the process itself.
nanoComposix as Your CDMO Partner
Enabling Your Success
We tailor our processes to your specific requirements. Our collaborative approach, process flexibility, and regulatory foresight support progress at each stage of development.
Our Approach
Feasibility
Review application requirements, define target specifications
Establish initial particle design and analytical methods
Screen multiple particle formulations
Assess scalability
Process Development & Scale
Define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
Assess Quality and CMC requirements
Perform analytical method development
Optimize scaled process to meet CQAs
Transfer to Manufacturing
Qualify suitable raw materials & equipment
Draft & release documentation through QMS (Manufacturing Batch Records, Test Methods, etc.)
Produce engineering batches, finalize process documentation
Production of Pre-Clinical & Clinical Trial Materials
Stage clean rooms & other controlled production areas
Manufacture material under suitable cGMP’s
Coordinate final release testing
What to Expect
Working with the team at nanoComposix has been a positive experience all around. Their knowledgeable scientists worked with us as we honed our early stage product design. They delivered as promised, and were flexible and creative problem solvers. We look forward to working with them more in the future.
Collaboration at Every Stage
We don’t just execute projects—we partner with you. Our scientists work closely with your team to ensure your goals guide every decision.
Flexibility Rooted in Partnership
We adapt to your needs because we’re invested in your long-term success, not just your next milestone.
Expertise Where It Counts
Our scientists address delivery, stability, and manufacturing hurdles with expertise in metal, silica, or polymeric nanoparticle synthesis and surface chemistry.
Facilities That Scale with You
ISO 13485-certified drug manufacturing FDA-registered and California licensed Modular cleanroom design for scale-up flexibility
Contact Us
We are excited to learn more about your project. Contact us today to talk with our experts.