GMP Nanomaterial Synthesis & Manufacturing

Fortis Life Sciences 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.

Talk to our Development Team

*For products within the scope of our ISO certification.


Why Partner With Us?

If you are looking for support with nanoparticle manufacturing, our team can offer assistance from start to finish, including proof of concept clinical trials, scaled production or cGMP manufacturing.

Our wide-ranging expertise means we can offer expert advice throughout the manufacturing process.

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 while maintaining cost efficiency and compliance.

Nanoparticle Manufacturing Expertise

We have been manufacturing nanoparticles for over 14 years. Our lead scientists have 80+ years of collective experience in nanomaterial fabrication, with an emphasis in metals and metal oxides like gold, silver, and silica.

GMP Experience & Capabilities

Our facility offers cGMP/ISO13485 compliant production and provides scaled nanoparticle manufacturing for medical devices, topical therapeutics, and combination (drug/device) products for preclinical and Phase I/II clinical trials.


GMP Development

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.

The steps below outline how we assist our clients with cGMP manufacturing services:

Click each step for details
 

Step 1 - Design Feasibility

Our design feasibility makes sure to validate the design, requirements and objectives of required services.

Concept

Determining product’s feasibility & identify the scope of the project

Research & Development

Defining user needs and identify corresponding design inputs

Step 2 - QMS Design Controls

We ensure to follow best quality practice when implementing QMS design.

Design Development

Identifying the stages, activities, responsibilities, resources & verification methods for design and development

Product Development

Establishing a product design with detailed associated specification

Step 3 - Transfer to manufacturing

Verification

Examining objective evidence to confirm specified requirements are met

Validation

Obtaining objective evidence to assure that a product meets the intended user needs

Step 4 - Custom & cGMP Manufacturing

Design Transfer

Transfer the process from development to commercial scale manufacturing; ensure all of the design requirements & product specification can be met in commercial production, and identify potential problems before transfer to commercial GMP

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Our Manufacturing Facility

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 accommodate projects that range from early stage feasibility to scaled production of clinical injectables.

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 chemical fume hood
  • Process and procedures in compliance with ISO 13485 and Phase I/ll Investigational Drug FDA guidelines

Facilities & Equipment

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.


Our Production Capabilities

At Fortis Life Sciences 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.

Here 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

Nanoparticles 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

Licenses and Registrations

  • 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

See our case studies and examples to see how we have helped our clients incorporate nanoparticles into different manufacturing applications:

  • Sienna Biopharmaceutical partnered with us 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 nanoplantes needed to be protected from the skin’s local environment. We 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: We 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

    Fortis Life Sciences 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 us 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, we 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 conducting 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 design history file was transferred to the customer

  • For this technology transfer, the client contracted with us 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. We worked closely with the client to ensure the procedures were comprehensively documented for successful transfer to outside laboratories while maintaining material quality and reproducibility. Our 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:

    • Our 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 our facility
    • We conducted a preliminary sensitivity analysis to determine the variables that affected the critical parameters of the synthesis
    • Our 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

  • 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 qualified as a second supplier for the nanoparticle component.

    GMP process development included:

    • Client provided us with their existing Manufacturing Master Record (MMR) and Batch Records and the synthesis was repeated in our R&D laboratory.
    • After developing a Quality Plan for the project, our team transferred and adapted the Batch Records and related into our QMS and performed engineering runs to qualify the process
    • Additional test methods were developed and validated and new suppliers were qualified
    • We 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 us as a verified second source
    • We were reviewed by the Client’s Notified Body and added as a Crucial Supplier to the Client’s CE Certification.
    • We became the primary supplier of the material to the client


Talk to Our GMP Team

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.