Commercial manufacturing products and services

We are proud to be able to offer our capabilities to fulfill Thermo Fisher Scientific's mission to enable our customers to make the world healthier, cleaner and safer.

  • High quality, reliable, responsive, and flexible
  • Dedicated to OEM and contract manufacturing
  • Experienced manufacturing facilities
  • Well-established global manufacturing footprint and infrastructure
  • Known and trusted contract manufacturing partner

Industries served

  • Life science tools and reagents for basic and biomedical research
  • In vitro diagnostics (IVD) and molecular diagnostics (MDx)
  • Therapeutics

OEM services and support

Leverage the expertise and infrastructure of Thermo Fisher Scientific, and have us manufacture products with your labels, in your packaging and inventoried in our facilities.

As a company providing thousands of products to customers globally, Thermo Fisher Scientific has developed expertise in supply chain management, product manufacturing and order fulfillment. And a as a vertically integrated organization, we have the ability to control reagent quality throughout the nucleic acid synthesis process.

GMP oligo manufacturing

Thermo Fisher Scientific’s GMP oligo manufacturing suite is located in Pleasanton, CA and is powered by more than 100 years of combined experience. Your organization will receive dedicated ordering and fulfillment services that are integrated into your systems and processes. Our capabilities extend to the production of oligonucleotide components for in vitro diagnostics (IVDs) and analyte-specific reagents (ASRs).

Applied Biosystems probe and primer analyte specific reagents (ASRs) are available to meet genetic analysis needs.
See more information about these products and how to order

Certifications

  • ISO 13485:2003
    The design, development (R&D), manufacture, distribution, of consumables and associated kits for life science research and for use as components of regulated kits manufactured and sold by diagnostic customers.  (FM 561905)
  • ISO 9001:2008
    The design, development (R&D), manufacture, distribution, of consumables for life science research using our assay and oligo-related products. (FM 534534)

    The design, manufacture, distribution, installation, and support of instrument systems used for life science research. (FM 570472)
  • Certified GMP
    The FDA Good Manufacturing Practice Regulations require that manufacturers, processors, and packagers of drugs, medical devices, certain food items, and blood take proactive steps to ensure that their products are safe, pure, and effective.
     

Commercial manufacturing process*

Proposal
  1. Sign CDA
  2. Assign PM
  3. Gather reqs.
  4. Assess gaps
  5. Outline project
  6. Supply agreement
Dev Support Process Dev
  1. Define strategies
  2. Optimize product
  3. Design packaging
  1. Develop process
  2. Validate process
  3. Mfg pilot lots
Custom Mfg Support Distribution
  1. Plan capacity
  2. In-source material
  3. Kitting, labeling
  4. Optimize process
  1. QC & compliance audits
  2. Business reviews
  1. Supply chain mgmt
  2. Relationshp mgmt
Proposal
  1. Sign CDA
  2. Assign PM
  3. Gather reqs.
  4. Assess gaps
  5. Outline project
  6. Supply agreement
Dev Support Process Dev
  1. Define strategies
  2. Optimize product
  3. Design packaging
  1. Develop process
  2. Validate process
  3. Mfg pilot lots
Custom Mfg Support Distribution
  1. Plan capacity
  2. In-source material
  3. Kitting, labeling
  4. Optimize process
  1. QC & compliance audits
  2. Business reviews
  1. Supply chain mgmt
  2. Relationshp mgmt

* Process may be modified on a project-by-project basis.

Learn more about our manufacturing capabilities