GMP & Contract Nanoparticle Manufacturing


Need materials for clinical trials, scaled production, or produced in compliance with cGMPs? NanoComposix offers a wide range of manufacturing services including nanoparticle development, fabrication, and final formulation under its ISO13485:2016 registered Quality Management System.

NanoComposix is a world leader in nanomaterial research and development, manufacturing, and processing. 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.

We offer contract research (CRO), contract development, and manufacturing (CDMO, CMO) services for a broad range of nanomaterials for use in pharmaceutical, biological, and medical device projects.

Why partner with nanoComposix?

  • Customized GMP Solutions: Because each project is unique, we work through a multi-stage process with each client to collaboratively develop a GMP Project Plan customized for the target application. We work with you to understand which requirements are most important to your specific market and intended use to optimize and maintain cost efficiency and regulatory compliance.
  • High-Volume Manufacturing: nanoComposix has capabilities to scale manufacturing by volume for nanoparticle suspensions and up to millions of tests per month for lateral flow assays.
  • Innovative Nano Experts: nanoComposix has been manufacturing nanoparticles for nearly 20 years. Our lead scientists are experts in nanomaterial fabrication, with an emphasis in metals and metal oxides including gold, silver, and silica. Our interdisciplinary team has a proven history of developing innovative solutions to tough problems and delivering cost-effective solutions that exceed customer expectations.
  • GMP Experience & Capabilities: Our facility offers cGMP compliant production operations within an ISO 13485:2016 certified Quality Management System to provide scaled nanoparticle manufacturing for use in medical devices, topical therapeutics, and combination (drug/device) products for preclinical and early stage clinical trials. We partner with local San Diego partners to provide a complete solution of particle fabrication, formulation, and sterile fill/finish.
  • Full Disclosure & Collaboration: Interested in seeing weekly or monthly summaries of our data and results? We provide written reports, access to lab notebooks, and regular conference calls to answer questions and collaboratively make strategic decisions about project direction.

Our experienced team of nanomaterials scientists and GMP experts offers customized solutions to meet your project’s needs. We work with you to select the appropriate performance metrics based on the final product’s requirements and identify the critical parameters to develop high yield, scalable, and reproducible manufacturing and processing methods.

Whether you work for a government agency, non-profit foundation, academic institution, or commercial business, the nanoComposix team can help you. Contact us today to put us to work on your toughest challenges.

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GMP Development Process

One of the challenges of GMP nanoparticle production is defining the appropriate level of controls and processes to appropriately manage risk. For each customer, we collaboratively work through a multi-stage process to define a GMP transition plan that is appropriate for the target application. At the end of each stage we conduct a design review to evaluate the work completed and to plan the next stage.

An example of a typical development process is provided below:

Case Studies

GMP Manufacture of Photothermal Nanoparticles

Contract R&D · Scale-up for Production · GMP for ISO13485 Commercial Supply

Client: Sienna Biopharmaceuticals, a clinical-stage biopharmaceutical company developing targeted topical products for medical dermatology and aesthetics

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:

  • Repeatedly producing the material under all the necessary controls to ensure the material meet all criteria of the formal Product Specification
  • Establishing a process flow diagram based on the R&D process and control points for In Process Quality Control (IPQC)
  • Developing a Manufacturing Master Record (MMR), including Master Batch Records (MBR) and a Bill of Materials with qualified suppliers
  • Process development to increase the standard batch size 100×
  • Process Failure Mode and Effects Analysis (pFMEA) to identify the risks in the material manufacturing
  • Several iterations of robustness work to ensure a consistent manufacturing process at commercial scale
  • Successful audits of nanoComposix to ensure QSR & ISO13485 requirements were met

NanoComposix is currently producing clinical supply material on-demand for this client and preparing for commercial production.

R&D of Nanoparticles as a Component of a Medical Device

Contract R&D · Product Development

Client: Diagnostic company

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:

  • Producing test reports and cataloguing in the design history file during the R&D stage
  • Finalizing a product specification and conducing an FEMA
  • Drafting manufacturing methods for each step and producing batch records for prototype runs
  • Qualifying raw material suppliers and receiving materials under the QMS
  • Holding design review meetings to review the specifications, manufacturing and test methods, and performing hazard analysis
  • Performing engineering runs to deliver released batches to the customer
  • At the end of the project, all manufacturing methods and the complete device history file was transferred to the customer

University Technology Transfer

R&D · Scale-Up · Establishing Pre-GMP Documentation

Client: Public university

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:

  • nanoComposix scientists traveled to the university to observe and meticulously record every detail of the synthesis performed at the university
  • Equipment and reagents were exactly duplicated for a successful repeat synthesis at nanoComposix
  • nanoComposix conducted a preliminary sensitivity analysis to determine the variables that affected the critical parameters of the synthesis
  • nanoComposix team drafted manufacturing methods at the small scale and documented additional details at critical steps
  • Investigated scaling at 5×, 20×, and 100× using new fabrication and processing methods. The scaled solutions were measured using validated test methods
  • Released batches were provided for safety and pre-clinical studies

Second Supplier for R&D Manufacturing

R&D · Product Development · Commercial Supply

Client: Private medical device company dedicated to dermatology therapies

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:

  • Client provided nanoComposix with their existing Manufacturing Master Record (MMR) and the synthesis was repeated in-house
  • After developing a Quality Plan for the project, nanoComposix transferred and adapted the MMR documents into the nanoComposix QMS and performed engineering runs
  • Additional test methods were developed and validated and new suppliers were qualified
  • nanoComposix produced a cGMP compliant qualification batch and delivered the material to the client for evaluation
  • At the successful completion of the project, the client approved nanoComposix as a verified second source

Want more examples of the many custom and contract R&D projects we’ve worked on? Visit our Contract R&D page.

Production Capabilities

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.

Below are just a few examples of our areas of expertise – please contact us to find out more about our capabilities and expertise.

Synthetic Fabrication Examples

  • Scaled production runs up to 10,000 liters
  • Core/shell nanoparticle fabrication and functionalization
  • Plasmonic nanoparticle engineering for vis/near-IR absorbers and scatters
  • Transfer to & from polar and non-polar solvents
  • Magnetic and fluorescent incorporation
  • High throughput concentration and processing using cross flow filtration
  • High temperature processing and calcination
  • Biofunctionalization and targeting

Nanoparticle Integration Examples

  • Thin film processing of nanoparticles
  • Photocatalytic composites
  • Self-healing carbon fiber composites
  • Nanoparticle diagnostics (e.g. lateral flow)
  • Surface enhanced raman spectroscopy (SERS) based sensors
  • High efficiency solar cells
  • Magnetic DNA-based tracer technologies

Facilities & Equipment

Over the years we’ve assembled an extensive set of analytical and manufacturing equipment that allows us to rapidly prototype solutions for our customers. Our 12,000 square foot state-of-the-art laboratory has a wide array of manufacturing and analytical equipment including an 800 square foot ISO 8 cleanroom and various labs containing the following equipment:

Optical Equipment

  • 2 dark field/bright field/fluorescent Olympus BX40/41 microscopes
  • Richardson dark field microscope
  • 3 Agilent 8453 UV-Visible spectrophotometers (200–1100 nm)
  • Jasco V670 UV-VIS-IR spectrophotometers (200–2300 nm)
  • Ocean optics spectrophotometers with integrating spheres for reflectance
  • 2 Hitachi F-4500 fluorescent spectrophotometers
  • Thermo Nicolet 6700 FTIR
  • Jasco FTIR
  • SpectraMax GEMI UV-Visible plate reader
  • SpectraMax 250 Fluorescent plate reader
  • Drick haze meter
  • Custom Raman spectrophotometer with 632 nm HeNe (22 mW), with 90 degree collection using a F2 lense/optical fiber coupled to a thermo-electric cooled Raman spectrometer (AvaSpec3648TEC, Avantes) after removal of Rayleigh scattering using a long pass filter (Semrock). The spectrometer has a 25 mm slit and order sorting filter for reduction of second order effects, and the grating provides a usable range from 640-840 nm with a resolution of 0.25 nm (FWHM).

Nanoparticle Characterization Instruments

  • Malvern Zetasizer Nano ZS dynamic light scattering/zeta potential instrument
  • CPS disc centrifuge analyzer DC24000
  • Malvern Nanosight NTA
  • JEOL 1010 100kV transmission electron microscope equipped with a 2K x 2K XR41B AMT digital camera

Other Analytical Instruments

  • Thermo Scientific Xseries 2 ICP-MS with automated sample handling is housed in a separate room along with a MARS SX microwave digester
  • Pyros Kinetix Flex endotoxin analyzer
  • Bruker Autoflex II MALDI-TOF
  • Mathis TCi thermal conductivity meter
  • Micromeritic BET surface area analyzer
  • Varian tap density meter
  • Tantec Contact Angle Instrument
  • Mettler liquid density meter
  • Oriel Merlin pyrometers
  • Brookfield viscometer
  • Balances (microgram to kilogram)

Chemical Synthesis Equipment

  • Qualified USP Purified Water system with > 10,000 L per day production capacity
  • 40 linear feet of vented fume hoods
  • 3 biosafety cabinets
  • 3 laminar flow cabinets
  • 2 Becton Ultra centrifuges (L80, XL-70)
  • Sorval Avanti J-25 high volume centrifuge
  • Centritech continuous centrifuge
  • Buchi B-290 spray dryer
  • 3 FTS Dura-Stop freeze dryers
  • Cup horn, probe and bath sonicators
  • Buchi rotary evaporator

Processing Equipment

  • 2 ultra centrifuges, 2 high speed, 10+ other benchtop
  • Microfluidics microfluidizer
  • Super critical dryer
  • LabRAM acoustic mixer
  • 2 VAC Atmosphere glove boxes
  • eBraun glove box with attached 600°C oven
  • Thermocraft furnaces
  • 5 Yamato convection drying ovens
  • Instron 100KN load frame
  • Trotec laser cutter
  • Chemat Technology spin coater
  • Fusion UV Systems curing station
  • Tormach mill

Lateral Flow Equipment

  • < 20% humidity dry room
  • Imagene Isoflow dispenser
  • Kinematic 2360 guillotine cutter
  • Kinematic laminator
  • Qiagen, cellmic, i-calQ readers

Cell Culture Facilities & Equipment

  • BSL2 room
  • Sterile biosafety hood
  • Incubator
  • Autoclave
  • Temperature controlled shakers