cGMP/QSR Compliant Nanomaterial Synthesis & Manufacturing
We are experts in nanomaterials fabrication for every phase of development from proof-of-concept through commercial manufacturing. Our team is ready to support your project from design and scale-up to full production under cGMP/QSR controls and our ISO 13485:2016 quality system.
With years of proven problem-solving expertise, our teams have succeeded in delivering complex nanoformulations where other CDMOs could not. We excel in tackling novel challenges and designing robust, tailored processes optimized for your product’s requirements.
Talk to one of our team members today to find out how we can help accelerate the development and commercialization of your regulated product.
Deep Nanoparticle Expertise
We provide manufacturing support for particles classed as drug substances, drug products, excipients, or components with capacity to support pre-clinical to Phase I and Phase II manufacturing.
Tailored Project Approach
We approach every project with a customized, holistic view. We build in the processes, documentation, and testing that suit your product, timeline, and regulatory goals.
Accelerated Technical Transfer
We help to de-risk your choice of high-volume manufacturing partner with accelerated tech transfers. Through early SME involvement and unparalleled attention to detail, we can avoid missteps and delays that slow down process and protocol transfers.
Subject Matter Experts In
- Silica (solid and mesoporous, colloids and coatings)
- Gold (spheres, rods, shells)
- Magnetite (iron oxide clusters, single domain cores)
- Silver (spheres, plates, cubes)
- Polymeric nanoparticles (nanoprecipitation and emulsion)
- Lipid coatings
- Custom transfers of novel materials and complexes
Our cGMP/QSR compliant facility is specifically designed for the fabrication, scale-up, and analysis of nanomaterial-based devices and drugs. Cleanroom spaces are designed to accommodate volumes from a few milliliters to hundreds of liters.
- 15,000 ft2 of lab space and manufacturing suites
- BSL-2 safety lab and low humidity dry room
- Flexible cleanroom spaces with biosafety cabinets and chemical fume hoods
- Processes and procedures in compliance with ISO 13485, 21 CFR part 210/211, 21 CFR part 820, and FDA guidelines
Manufacturing Certifications, Registrations, and Licenses
- ISO 13485:2016 Certificate
- FDA Medical Device Establishment Registration
- State of California Medical Device Manufacturing License
- FDA Drug Establishment Registration
- State of California Drug Manufacturing License
Development & GMP Manufacture of a Mesoporous Silica Based Cancer Therapeutic
A pharmaceutical company approached nanoComposix to develop mesoporous silica particles as a key component in their cancer immunotherapy. Feasibility testing of several variants was completed to identify the key material properties and specifications needed to enhance the immunotherapy. nanoComposix developed processes to scale the fabrication 1000-fold and manufactured material under cGMP controls for pre-clinical testing.
Scaled Polymeric Nanoparticles for Immunotherapy
nanoComposix engaged in close collaboration with a client to comprehensively develop and manufacture a cutting-edge PLGA nanoparticle-based immunotherapy. Work began by successfully integrating the client’s API into a nanoparticle tailored to the unique requirements of the therapy and progressed through scale-up, process development, transfer to manufacturing, and the production of GMP material for Phase I and Phase II clinical trials.
Technical Transfer of a GMP Topical Photothermal Therapeutic
A client required a second source for a nanoparticle component in their topical acne therapeutic. A Manufacturing Master Record (MMR) and Manufacturing Batch Records (MBRs) were provided to nanoComposix for all intermediates, and the synthesis of the nanoparticle component was successfully replicated at nanoComposix. Engineering runs were performed using draft batch records while additional test methods were developed and validated. nanoComposix led qualification of all raw material suppliers. A cGMP-compliant qualification batch and commercial GMP lots were produced and delivered to the client.
Photothermal Nanoparticle for Hair Removal
nanoComposix co-developed and manufactured a photothermal hair removal treatment for Sienna Biopharmaceuticals. This topical therapeutic utilized silica-shelled silver nanoplates that were developed and optimized by nanoComposix, first under R&D controls and later under the nanoComposix Quality Management System. During the R&D phase, nanoComposix developed a process to fabricate and encapsulate nanoplates for prototyping and proof of concept demonstration in pilot studies.