nanoComposix specializes in the development and manufacturing of devices and drugs with nanomaterial components. We are experts in the fabrication and scale-up of nanomaterials for use in products that require ISO13485:2016 and cGMP compliant quality systems. Talk to one of our team members today to find out how we can help accelerate the development and commercialization of your regulated product.
One of the challenges of GMP manufacturing is determining the appropriate controls required to minimize risk at each stage of the development process.
For each customer, we collaboratively develop a GMP manufacturing plan that implements stage-appropriate controls required for FDA compliance while minimizing project time and costs.
Our cGMP compliant facility is specifically designed for the fabrication, scale-up, and analysis of nanomaterial based devices and drugs. Cleanroom spaces are designed to accommodates projects that range from early stage feasibility to scaled production of clinical injectables.
For nearly 20 years, our team has been developing innovative solutions to meet the specific product requirements of our customers in fields ranging from nanomaterial manufacturing to medical diagnostics. We specialize in cGMP-compliant fabrication of inorganic nanomaterials, including metal and metal oxide core-shelled materials.
We also have experience with controlled release nanoparticles made from polymers such as PLGA. Past projects have included novel custom nanoparticle fabrication, manufacturing scaling from mg to kg scales, and collaborative custom development projects where we solve R&D and manufacturing scale-up challenges for commercial launch of nano-enabled products.
* Equipment that is available for GMP use.
Sienna Biopharmaceutical partnered with nanoComposix to co-develop a photothermal acne treatment made of nanoparticles. The technology is made possible by highly concentrated silica coated silver nanoplates that are introduced into the hair follicles of over-productive oil glands. Standard dermatology lasers are then used to locally heat and impair the nearby sebaceous glands, reducing oil production and acne. In order to make this therapy successful, the silver nanoplates needed to be protected from the skin’s local environment. NanoComposix worked closely with Sienna to design and optimize the silica encapsulation, maximizing the formulation’s stability on skin and thereby increasing treatment efficacy.
Transfer to GMP manufacturing under QMS: NanoComposix developed a working prototype and helped Sienna define a formal Product Speciﬁcation, a critical early phase of GMP development. The transfer to GMP manufacturing for clinical supply and preparation for commercial production included:
NanoComposix is currently producing clinical supply material on-demand for this client and preparing for commercial production.
This client was developing a fluorescent-based lateral flow device for commercialization and was seeking a partner to produce ultra-bright nanoparticles that would help them achieve their sensitivity needs for their assay, as well as lateral flow assay development and manufacturing partner. After evaluating other nanoparticle and lateral flow development companies, they selected nanoComposix to develop a novel ultra-bright reporter particle for their assay and perform the assay development needed for pilot manufacturing. Over several months of collaboratively working with the client on particle and assay development, nanoComposix enabled them to meet their rigorous sensitivity targets for the project and provided all the necessary methods and SOPs for pilot scale manufacturing.
Process development included:
For this technology transfer, the client contracted nanoComposix to assist in transferring their nanoparticle-enabled immune-stimulant technology from the university lab where it was developed to a commercial lab and to begin to establish manufacturing SOPs and to scale up synthesis production. nanoComposix worked closely with the client to ensure the procedures were comprehensively documented for successful transfer to outside laboratories while maintaining material quality and reproducibility. The nanoCompmosix team also investigated potential scale-up options, which would be required to reduce costs and produce the material at the target price-points for their end application.
Technology transfer steps included:
This customer had been producing a proprietary topical therapeutic with a nanoparticle component and required a second supplier for their commercial technology. nanoComposix worked with them to replicate their established synthesis protocols, testing, and release procedures under our QMS so that we could be validated as a second supplier for their nanoparticle component.
GMP process development included:
At nanoComposix we have completed over a thousand custom projects ranging from self-healing aerospace composites to targeted cancer drug delivery. We work closely with each client to fully understand their needs and the requirements for the end application so that we can optimize quickly while keeping aligned with the customer’s goals. In most cases we’re able to maximize our chances for success by bringing the client’s end metric in-house. By having the analytical measurements readily available to determine if both the nanoparticle fabrication and integration are successful, we can rapidly iterate the nanoparticle chemistry and processing to help achieve the end-goal quickly and reduce overall development costs.
We’re here to help!
Our knowledgeable technical staff is available to help with your specific product, project, and technical questions. We look forward to learning more about what you’re doing and how we can help you succeed.
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