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The right partner makes all the difference

If you’re involved in the commercial development of diagnostic, therapeutic, or life science products, you’ve come to the right place. When you bring our experienced Thermo Fisher Scientific Commercial Supply team on board, whether your project is large or small, your commercialization goals become our goals.

How we help you get there

You are going to face challenges on your product development journey. Utilizing our OEM services can help you overcome them.

With so much at stake, it’s no wonder companies of all sizes have collaborated with Thermo Fisher to successfully launch commercial products. They’ve entrusted us to alleviate many of the stressors associated with product development, and you can, too. That way, you’ll be able to focus on your technology with confidence.

Why partner with Thermo Fisher scientific

Take no chances in the effort to achieve your goals. Partner with us for the quality, security of supply, customization, and expertise you can expect from the world leader in serving science.

Contact us

 

When you rely on us for manufacturing, you’ll gain the advantage of our uniquely robust processes. You can have confidence in the quality of your product because of our commitment to manufacturing excellence and compliance with regulatory guidelines.

Bring your vision into being in our state-of-the-art manufacturing centers. True to our company-wide commitment to advancing life sciences, your products will be manufactured in facilities that have set a high standard for the biotechnology industry and offer:

  • Innovation—combining advances in formulation and assembly with the power of computerized tracking and controls
  • Maximum flexibility—ability to configure your product with customized buffer formulations at any scale
  • Reproducibility—automated liquid handling and stringent quality control
  • Confidence—sites are audited and approved for use by major companies; we employ Six Sigma and Lean Manufacturing processes to help ensure superior quality and low costs
  • Robust manufacturing and cold-chain capabilities
    • Global reach with over 50 distribution and manufacturing sites
    • Robust manufacturing that meets applicable global regulatory requirements
    • Superior cold chain helps ensure product quality and performance
    • Dedication to continual improvement, driving productivity and sustainability
  • Compliance*
    • Certified quality system with ISO 9001, ISO 13485, and ISO 14001 status
    • US 21 CFR Part 820 Quality System (current good manufacturing practice (cGMP))
    • Manufacturer of Class I, II, and III medical devices along with general-purpose reagents under USDA guidelines
    • Media production sites are registered with the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA)
    • Selected sites are good laboratory practice (GLP) - accredited

*Certain regulatory standards available at specific sites only

You shouldn’t have to worry about changes in raw materials that may require you to retest your product. Partnering with us helps ensure the security of your raw materials supply, which is crucial to the development and manufacture of a reliable commercial product. We have a system of strong safeguards to help ensure supply security, including backup supplies and supply guarantee agreements. Additional security measures, which can help you avoid delays and setbacks in manufacturing, include:

  • Advanced change control notifications
  • Supply agreements
  • A global manufacturing footprint
  • Comprehensive controls over raw materials and processes
  • Multiple manufacturing sites
  • Financial stability
  • Confidentiality

Ensuring security of supply in commercial development

GlobalManufacturing-Map

Your commercial assay is likely to require customization to fit your precise specificity, sensitivity, and workflow needs. Our products and services are not “one size fits all.” When you partner with us, we work closely with you to build assay components to your exact specifications. From assay design to workflow optimization—whatever your needs, our custom services team is there for you. In fact, many of our custom services and products are available exclusively to our Commercial Supply partners.

Custom services include:

  • Assay design
  • Workflow development and optimization
  • Performance testing
  • Bridging studies
  • Guardbanding
  • Verification testing
  • Analytical validation testing
  • Stability studies

We can customize your products in a number of ways:

  • Fill volume
  • Formulation
  • Packaging
  • Private labeling
  • Bulk ordering

Case Study: Improved performance through custom plastics

Case Study: Take your assay anywhere

Collaboration in Molecular Diagnostics Enzyme Development

Any company—but especially a smaller or newer company—can benefit greatly by working closely with us. That’s because Thermo Fisher has extensive experience developing and commercializing products, and we can leverage our leading-edge technologies to benefit you. Your Commercial Supply Business Development Manager will serve as your new project champion and help connect you with the right resources in R&D, Manufacturing, Regulatory Affairs, and more. Having a dedicated, experienced Thermo Fisher advocate on your team to guide you through the process of bringing a product to market can help you avoid costly missteps.

We have partnered with companies in numerous focus areas, including:

  • Oncology
  • Infectious diseases
  • Reproductive health
  • Neurobiology
  • Cardiovascular studies
  • Hematology
  • Cell therapy
  • Agricultural and environmental applications
  • Food safety
  • Research tools

Molecular evolution in molecular diagnostics enzyme development

When you rely on us for manufacturing, you’ll gain the advantage of our uniquely robust processes. You can have confidence in the quality of your product because of our commitment to manufacturing excellence and compliance with regulatory guidelines.

Bring your vision into being in our state-of-the-art manufacturing centers. True to our company-wide commitment to advancing life sciences, your products will be manufactured in facilities that have set a high standard for the biotechnology industry and offer:

  • Innovation—combining advances in formulation and assembly with the power of computerized tracking and controls
  • Maximum flexibility—ability to configure your product with customized buffer formulations at any scale
  • Reproducibility—automated liquid handling and stringent quality control
  • Confidence—sites are audited and approved for use by major companies; we employ Six Sigma and Lean Manufacturing processes to help ensure superior quality and low costs
  • Robust manufacturing and cold-chain capabilities
    • Global reach with over 50 distribution and manufacturing sites
    • Robust manufacturing that meets applicable global regulatory requirements
    • Superior cold chain helps ensure product quality and performance
    • Dedication to continual improvement, driving productivity and sustainability
  • Compliance*
    • Certified quality system with ISO 9001, ISO 13485, and ISO 14001 status
    • US 21 CFR Part 820 Quality System (current good manufacturing practice (cGMP))
    • Manufacturer of Class I, II, and III medical devices along with general-purpose reagents under USDA guidelines
    • Media production sites are registered with the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA)
    • Selected sites are good laboratory practice (GLP) - accredited

*Certain regulatory standards available at specific sites only

You shouldn’t have to worry about changes in raw materials that may require you to retest your product. Partnering with us helps ensure the security of your raw materials supply, which is crucial to the development and manufacture of a reliable commercial product. We have a system of strong safeguards to help ensure supply security, including backup supplies and supply guarantee agreements. Additional security measures, which can help you avoid delays and setbacks in manufacturing, include:

  • Advanced change control notifications
  • Supply agreements
  • A global manufacturing footprint
  • Comprehensive controls over raw materials and processes
  • Multiple manufacturing sites
  • Financial stability
  • Confidentiality

Ensuring security of supply in commercial development

GlobalManufacturing-Map

Your commercial assay is likely to require customization to fit your precise specificity, sensitivity, and workflow needs. Our products and services are not “one size fits all.” When you partner with us, we work closely with you to build assay components to your exact specifications. From assay design to workflow optimization—whatever your needs, our custom services team is there for you. In fact, many of our custom services and products are available exclusively to our Commercial Supply partners.

Custom services include:

  • Assay design
  • Workflow development and optimization
  • Performance testing
  • Bridging studies
  • Guardbanding
  • Verification testing
  • Analytical validation testing
  • Stability studies

We can customize your products in a number of ways:

  • Fill volume
  • Formulation
  • Packaging
  • Private labeling
  • Bulk ordering

Case Study: Improved performance through custom plastics

Case Study: Take your assay anywhere

Collaboration in Molecular Diagnostics Enzyme Development

Any company—but especially a smaller or newer company—can benefit greatly by working closely with us. That’s because Thermo Fisher has extensive experience developing and commercializing products, and we can leverage our leading-edge technologies to benefit you. Your Commercial Supply Business Development Manager will serve as your new project champion and help connect you with the right resources in R&D, Manufacturing, Regulatory Affairs, and more. Having a dedicated, experienced Thermo Fisher advocate on your team to guide you through the process of bringing a product to market can help you avoid costly missteps.

We have partnered with companies in numerous focus areas, including:

  • Oncology
  • Infectious diseases
  • Reproductive health
  • Neurobiology
  • Cardiovascular studies
  • Hematology
  • Cell therapy
  • Agricultural and environmental applications
  • Food safety
  • Research tools

Molecular evolution in molecular diagnostics enzyme development