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Nanomedicine Manufacturing Services

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.

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.

  • 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
  • Process and procedures in compliance with ISO 13485, 21 CFR part 210/211 compliant and FDA guidelines

cGMP/QSR Manufacturing Certifications

  • DUNS Number: 159070825
  • ISO 13485:2016 Registrar: Perry Johnson Registrars, Inc. (PJR) Certificate Number: C2021-01104-R1
  • FDA Medical Device Establishment Registration: 3010366543
  • State of California Medical Device Manufacturing License: 104574
  • FDA Drug Establishment Registration FEI: 3010366543
  • State of California Drug Manufacturing License: 104574

Case Studies

Development to 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. Development progressed to scale-up efforts, and nanoComposix developed processes to scale the manufacture of this material 1000-fold.

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 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.

Photothermal Nanoparticle for Hair Removal

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.

Contact us about your project