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 deep expertise in reproducible and scalable nanoparticle development, we have a proven track record of transferring novel nanomedicine platforms while maintaining their functionality at scale.
Talk with our experts today to find out how we can help accelerate the development and commercialization of your regulated product.
Our expert scientists and engineers have decades of experience fabricating nanomaterials and conjugating synthetic and natural biomaterials to nanoparticle surfaces. We have a proven track record of fabricating stable and reproducible formulations of customers’ nanoscale active and excipient materials.
Our scientists collaborate with you on all aspects of your technical needs and design a project that is tailored to your specific product and regulatory pathway. Our experts are in constant contact with your team to make timely and informed decisions during the development process. We work across the Fortis Life Sciences family and with outside partners to ensure your project has the right materials and supporting services.
We understand the need to reach your milestones rapidly and are here to help you accelerate processes to meet your goals. Our R&D, process development, and manufacturing teams work flexibly and collaboratively to get you data and materials needed to support toxicology studies, clinical trials, and beyond.
We provide manufacturing support whether your particle is classed as a drug substance, drug product, excipient, or component, with scale to support you from pre-clinical studies to Phase I and Phase II manufacturing. We have experience developing nanoparticle formulations for topical, oral, intravenous, subcutaneous, and intranasal (spray) administration routes. We are happy to work with your team to apply interdisciplinary experience in optimizing materials, excipients, and buffer formulations based around your intended administration route to maximize the efficacy of your product. With end-to-end support, our teams are here to help accelerate your development and commercialization goals.
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.
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 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.
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.