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Nanomedicine Contract Research and Development

nanoComposix has a multidisciplinary team of scientists with backgrounds in chemistry, physics, engineering, and earth sciences. We have worked with hundreds of different clients to develop nanomaterials, composites, and formulations with tailored optical, physical, and bio-functional properties.

Our expertise in the fabrication and scale-up of nanomaterials for use in products that require ISO 13485:2016 and cGMP compliant quality systems make us uniquely suited to the challenges of diagnostic applications.

Talk to our experts today to find out how we can help develop and optimize your nanoparticle systems.

Talk to our experts


Why Choose nanoComposix?

Scientific Rigor

We select performance metrics based on the requirements of the final product and identify the critical parameters for the development of high-yield, scalable and reproducible manufacturing and processing methods.

Innovation

Our interdisciplinary team has a proven track record of developing innovative solutions to tough problems and delivering cost-effective solutions that exceed our customers’ expectations.

Full Disclosure

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 the project direction.

Confidentiality

Our partnership, as well as all work and data associated with the R&D effort, will remain confidential.

Whether you work for a government agency, non-profit foundation, academic institution, or commercial business, the nanoComposix team can help you achieve your project milestones.


Core Capabilities

Custom Nanoparticle Synthesis, Optimization, and Scale-Up

Whether you need proof-of-concept for a novel therapeutic, a customized catalog product, or the transfer and optimization of your process, we have extensive experience in bringing your nanotherapeutic to the stage you need it to be.

Surface Functionalization and Biofunctionalization for Targeted Delivery and Biocompatibility

We employ a variety of methods to create the custom nanotherapeutic with your desired biofunctionalization using efficient and effective chemistries. Custom biofunctionalizations include antibodies, Fab fragments, VHH antibodies, RNA, and DNA.

Drug Loading, Encapsulation, and Controlled Release

We have experience tuning the properties of nanotherapeutics to deliver a payload on the desired timescale and determine the most effective methods for tracking release.

Optical & IR Tuning for In-Vivo Imaging, Theranostics, & Photothermal Therapy

We can help you select the right nanoparticle composition to yield the desired optical characteristics for your nanotherapeutic.

Magnetic & Multi-Functional Particle Design and Production

We have extensive experience developing core-shell nanoparticles which have been biofunctionalized for specific applications.

Extensive Nanoparticle Characterization Expertise

Both our catalog and custom-designed nanoparticles undergo significant characterization. We also offer stand-alone characterization of your nanomaterials on our services webpage and can work with you to develop a custom assay for your nanotherapeutic.


Key Materials

Explore our core capabilities and expertise


Analytical Capability Highlights

Precisely engineered and highly characterized – at nanoComposix we take analytics very seriously. We thoroughly characterize not only nanoparticle morphologies and surfaces, but also formulation characteristics and functionality. Our scientific team is not limited by commercially available solutions, and will often develop custom assays to suit unique nanotherapeutic applications.

Particle Morphology

  • DLS (Dynamic Light Scattering) – hydrodynamic diameter, polydispersity
  • TEM (Transmission Electron Microscopy) – shape, size of inorganic and nanoscale materials
  • SEM (Scanning Electron Microscopy) – shape, size of polymeric and nanoscale-microscale materials
  • Brightfield Optical Microscopy – shape, size of microscale-macroscale materials
  • BET (Brunauer-Emmett-Teller) – surface area, pore size

Particle Surface & Function

  • ELISA (Enzyme-Linked Immunosorbent Assays) – direct and indirect functional performance
  • Multiplexed Luminescence Assays – simultaneous detection of multiple analytes from a single sample
  • LFA (Lateral Flow Assays) – qualitative and quantitative performance against a test and control line
  • FTIR (Fourier Transform Infrared Spectroscopy) – chemical group identification
  • Zeta Potential – surface charge

Optical Properties

  • UV-Vis/NIR (Ultraviolet-Visible/Near Infrared Spectroscopy) – absorbance, scattering at various wavelengths
  • Fluorescence Spectroscopy – fluorescent property qualitative and quantitative analysis
  • Darkfield Optical Microscopy – optical method to detect nanoparticle scattering and coupling effects

Protein Characterization

  • BCA (Bicinchoninic Acid Assay) – total protein content
  • HPLC (High Performance Liquid Chromatography) – qualitative and quantitative protein, PEG, and lipid analysis
  • SDS-PAGE (Gel Electrophoresis) – qualitative and quantitative protein analysis
  • NanoDrop – low volume, rapid protein quantification

Formulation Characterization

  • Endotoxin – endotoxin (a component of gram-negative bacteria cell wall) concentration
  • DLS (Dynamic Light Scattering) – particle stability, polydispersity
  • ICP-MS (Inductively Coupled Plasma Mass Spectrometry)– metal ion concentration
  • Karl Fischer Coulometric Titration – water content analysis
  • FTIR (Fourier Transform Infrared Spectroscopy) – residual reagent analysis

Explore our analytical services offerings or contact us for additional information.


Facilities

Our facility is specifically designed for the fabrication, scale-up, and analysis of nanomaterial-based devices and drugs. Cleanroom spaces are designed to accommodate projects that range from early-stage feasibility to scaled production for Phase I & Phase II clinical studies.

Our lab space includes:

  • 8,000 ft2 of R&D and production labs
  • BSL-2 safety lab and low humidity dry room
  • ISO 8 cleanroom with biosafety cabinets and chemical fume hoods
  • Processes and procedures in compliance with ISO 13485 and FDA guidelines

Manufacturing Certifications, Registrations, and Licenses


Case Studies

Cardiovascular Disease Treatment

Gold nanoparticles were coated with the client’s proprietary biologic to target and treat cardiovascular disease. The gold nanoparticle cores served as both a biocompatible scaffold and a means to track the pharmacokinetics of the platform. nanoComposix completed a technology transfer of the client’s existing analytical methods and processes, successfully scaled the procedure from a milliliter to a liter scale for future manufacturing, and optimized the lyophilization and storage conditions of the therapeutic.

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.

Antibacterial Silver Nanoparticles for Use in a Wound Dressing

A physician client treating patients with diabetic wounds contacted nanoComposix to manufacture silver particles to be used on the surface of a wound compression dressings. The resulting product was utilized in a medical case study for the treatment of wounds and diabetic ulcers.

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.

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. qualification. A cGMP-compliant qualification batch and commercial GMP lots were produced and delivered to the client.

Targeted Silica-coated Iron Oxide Nanoparticles for in-vivo Delivery to Tumors

Magnetite nanoparticles with a silica shell were designed by nanoComposix and functionalized with a humanized anti-prostate-specific membrane antigen using a covalent binding strategy for cell-specific targeting. Non-specific binding was minimized via the development of a mixed monolayer of polyethylene glycol molecules at the particle surface. Feasibility testing showed these nanoparticles were extremely stable and had excellent specific targeting ability. In-vivo data showed targeted delivery and tumor reduction when the magnetic nanoparticles were heated via an applied alternating magnetic field.

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 this material 1000-fold.

Development of an Oligonucleotide Conjugated Gold Nanoparticle Cancer Therapeutic

The sponsor of an oligonucleotide drug candidate contracted nanoComposix for the development of a custom gold nanoparticle conjugate. nanoComposix designed, optimized, and characterized this formulation for enhanced binding and developed a companion lateral flow immunoassay to quickly and easily test the functionality of these particles prior to in-vitro or in-vivo testing. nanoComposix provided the sponsor with complete characterization including TEM visualization, UV-Visspectra pre and post conjugation, and stability data.

Contact us about your project