Your partner FOR particle-based therapeutics Nanomedicine CDMO Services
We work with you to develop the particle system and manufacturing process around your active ingredient, target performance, and next development milestone.
Schedule a Consultation20+ YearsNanoparticle expertise
ISO 13485Certified quality system
Made in USASan Diego, California
26 preclinical development programs + 50 GMP batches supported
Particle Platforms for Therapeutic Development
Select a carrier for your active ingredient or a particle whose optical or magnetic properties support the intended therapeutic approach. Platform choice shapes loading, release, stability, surface chemistry, and scale-up.
PLGA & Other Polymers
Develop nanoparticles and microparticles for active encapsulation and controlled release. Tune polymer selection, loading, release behavior, surface chemistry, and stability around your target product profile.
Silica & Mesoporous Silica
Design particles and pores for active loading and release. Tailor pore size, surface chemistry, and dispersion format, including independent modification of pore and external surfaces.
Metal & Metal Oxide Systems
Engineer particle cores, coatings, and conjugates for photothermal, magnetic, and imaging-enabled therapeutic programs. Relevant platforms include gold, iron oxide, and composite particle systems.
Nanomedicine CDMO Services for Your Development Stage
Engage at the stage that fits your program, from early formulation work through process scale-up and manufacture. Our R&D and Manufacturing Science & Technology (MSAT) teams collaborate across development, allowing process risks and scale-up considerations to be addressed early.
Feasibility & Formulation
Evaluate formulations, optimize active ingredient loading, refine particle properties, and assess release, stability, and surface functionality against your target profile.
Process Development & Scale-Up
Define critical quality attributes and process parameters, refine processing and purification, and establish analytical methods for larger-scale work.
Technology Transfer
Transfer an established particle process into a controlled manufacturing environment. Scope qualification, engineering work, test methods, and documentation around your process.
Manufacturing & Supply
Plan material production around your program needs, including GMP manufacturing where appropriate. Align controls, release testing, documentation, and supply requirements before production.
Designing for Scale from the Start
Our R&D and MSAT teams work closely to assess process risks and begin evaluating scalable unit operations during early development rather than waiting until the formulation is finalized. This early collaboration enables a more deliberate path from technical feasibility to a repeatable manufacturing process.
Custom Particle Development Capabilities
Particle size
Nanoparticle and microparticle formats
Release behavior
Controlled release profile development
Payload strategy
Encapsulation of hydrophobic and/or hydrophilic payloads
Loading performance
Loading capacity and encapsulation efficiency optimization
Surface chemistry
PEGylation, ligand attachment, and surface functionalization
Characterization
Analytical characterization and batch-specific data packages
Scale-up readiness
Process risk assessment, scalable unit operations, and reproducibility studies
Quality support
Support for programs requiring ISO 13485 and cGMP-aligned capabilities
Characterize What Matters
Utilize project-specific measurements to compare designs, define specifications, troubleshoot processes, and assess reproducibility.
Size & Morphology DLS, LDA, TEM, SEM, BET
Surface Chemistry Zeta potential, FTIR, pH titration
Conjugation, Loading & Release UV-Vis, fluorescence, HPLC, ELISA
Optical Properties UV-Vis, fluorescence, dark-field
Composition & Concentration ICP-MS, HPLC
Custom Characterization Developed 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.
Material Format & Downstream Processing
Discuss material format, concentration, packaging, storage, and documentation needs during scoping, including requirements for API-containing systems.
nanoComposix does not provide sterile materials or perform aseptic processing or fill-finish operations. We will work with you and a qualified manufacturing partner to plan downstream activities as required.
Discuss Your Nanomedicine Project
Let's define the nanomedicine CDMO services your program needs. Share your particle system or active ingredient, current stage, next milestone, and target quantity and timing where known.
A brief, nonconfidential overview is enough to start.
Nanomedicine CDMO Programs in Practice
Examples from prior collaborations include:
PLGA Immunotherapy
A PLGA immunotherapy program required an API-containing formulation that could advance beyond early development. The work progressed through formulation development, scale-up, manufacturing transfer, and GMP production.
Material supplied: GMP material for Phase I and II clinical trials.
Topical Photothermal Therapeutic
An acne-therapeutic developer needed to transfer an established nanoparticle process. The project covered supplier qualification, engineering work, and manufacturing qualification.
Material supplied: Qualification and commercial GMP lots.
Polymeric Topical Formulation
A topical product developer needed to move beyond milligram-scale experiments. The polymeric nanoparticle process was optimized and scaled while maintaining critical particle attributes.
Scale reached: 0.5 kg in the reported project.
Imaging-Enabled Iron Oxide
An imaging-enabled program required iron oxide nanoparticles with specified size and magnetic properties at greater scale. The process was refined and scaled around those target attributes.
Material supplied: Multiple batches for clinical trials.
FAQs: Nanomedicine CDMO Services
Can you work with our existing formulation or process?
Yes. We can support formulation optimization, scalability assessment, or transfer of an established process. Share your current specifications, analytical methods, and the change you need to make.
Do we need to select a particle platform before contacting you?
No. We’ll work with you to identify the particle platform that best fits your active ingredient, therapeutic goals, and next milestone.
How are cost, timing, and deliverables defined?
We’ll define the project scope with you based on formulation complexity, analytical requirements, material needs, and documentation expectations. The proposal will outline planned deliverables, timing, review points, and costs before work begins.