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GMP Manufacturing

nanoComposix 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 GMP Team

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.

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

Download Facilities & Equipment (PDF)

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 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.

+ Optical Equipment

+ Nanoparticle Characterization Instruments

+ Other Analytical Instruments

+ Chemical Synthesis Equipment

+ Processing Equipment

+ Lateral Flow Equipment

+ Cell Culture Facilities & Equipment

* Equipment that is available for GMP use.

Case Studies

+ GMP Manufacturer of Photothermal Nanoparticles

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

+ University Technology Transfer

+ Second Supplier for cGMP Manufacturing

Our 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.

+ Synthetic Fabrication Examples

+ Nanoparticles Integration Examples

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.

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