cGMP/QSR Compliant Nanomaterial Synthesis & Manufacturing
We are experts in the fabrication and scale-up of nanomaterials that are manufactured under cGMP/QSR and ISO13485:2016 quality systems. Our team is ready to support your project from design and scale-up to full production under cGMP or QSR.
We excel in tackling novel challenges and designing robust, tailored processes that are unique to your product’s requirements. With years of proven problem-solving expertise, our teams have succeeded in delivering complex nanoformulations where other CDMOs could not.
Talk to one of our team members today to find out how we can help accelerate the development and commercialization of your regulated product.
We provide manufacturing support for particles classed as drug substances, drug products, excipients, or component with capacity to support pre-clinical to Phase I and Phase II manufacturing.
We take a non-formulaic approach to every project, making sure we build in only the steps, processes, and tests that suit your goals with a holistic view based on your timelines and regulatory goals.
With scientific involvement from the start and intense attention to detail, we can avoid missteps and delays that slow down the processes and protocol transfers. Accelerated tech transfers offer you the ability to de-risk choosing your manufacturing partner.
Material-specific experts in:
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.
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. Development progressed to scale-up efforts, and nanoComposix developed processes to scale the manufacture of this material 1000-fold.
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.
A client required a second source for a topical acne therapeutic with a nanoparticle component. 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 as required. nanoComposix led qualification of all raw material suppliers. A cGMP-compliant qualification batch and commercial GMP lots were produced and delivered to the client.
nanoComposix assisted in the development and manufacture of 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 NCX 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. Read case study.