NanoComposix has recently received its drug manufacturing license from the Food and Drug Branch of the State of California Department of Public Health.
Up until now, NanoComposix had been involved in nanomaterials, providing services in nanotechnology development and contract manufacturing. Since 2017, the San Diego-based company has been manufacturing nanomaterials for biotech clients under cGMPs (QSR, 21 CFR 820).
The focus is still on the development and scale-up of cGMP manufacture of colloidal nanomaterials, but just with added capacity to contribute to subsequent drug manufacture.
This is in order to streamline clients experience through the process of producing drugs with a nanotech aspect. As a CMO, the company will have in-house drug manufacturing, ensuring the client base have the flexibility to utilise one vendor throughout the product life cycle.
Founder & President Dr Steve Oldenburg said: “This opens up a new set of capabilities for our clients and allows us to align with our long-term corporate goal of supplying nanotechnology-enabled products from concept through commercialisation.”
Since 2004, NanoComposix has been providing development, fabrication, processing, and scale-up services to commercialise nanomaterials in several applications, including in vitro diagnostics, therapeutics, devices, plasmonic, and preclinical drugs.
The company’s facility includes a qualified ISO Class 8 cleanroom dedicated to cGMP manufacture of nanomaterial-based medical devices and drugs.
