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Security of supply. Customized solutions. Unmatched expertise.OEM Solutions: Custom Commercial SolutionsThe right partner makes all the difference. |
Bringing a diagnostic or life science product to market is an uphill task requiring continuous innovation, quality materials, and navigation through the regulatory landscape. We can help take your product to market with speed and precision and without the stress and costs associated with do-it-all on your own. As a vertically integrated organization, Thermo Fisher Scientific has the experience and expertise to support all phases of product development, from concept development to commercialization. Our OEM solutions and services include turnkey and custom products. Figure 1 lists all our OEM offerings.
Our OEM team specializes in helping you bring your solutions to market faster. The advantages of Thermo Fisher Scientific OEM solutions are listed in Figure 2.
OEM solutions and services
Figure 1. Snapshot of OEM services.
Figure 2. Advantages of OEM solutions.
Assurance of quality marked by reduced batch variability and robust quality control testing to help meet regulatory standards.
Accreditations and regulatory compliance*
- ISO 9001, ISO 13485, and ISO 14001 certified quality systems
- US 21 CFR Part 820 Quality System (current good manufacturing practice, cGMP)
- Class I, II, and III medical devices and general-purpose reagent certified manufacturer under USDA guidelines
- US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) registered media production sites
- Select good laboratory practice (GLP) accredited sites
- Readily available and downloadable Certificates of Analysis (CoA) and Certificates of Conformance (CoC)
*Note: Certain regulatory standards are available at specific sites only.
Consult with our R&D experts to set off your project on the right track, execute projects with precision, and troubleshoot projects inflight. Our manufacturing teams have supported a wide range of products across a diverse group of therapeutic and diagnostic focus areas including oncology, infectious disease, cell therapy, agricultural and environmental applications, and food safety.
Execute your unique vision through a wide selection of off-the-shelf and custom manufacturing options and services. These include component alterations, modified reagents, molecular synthesis, novel consumables, custom packaging, and other end-to-end product development.
We have products dedicated to different workflows, technologies, and applications, including raw materials, reagents, instruments, hardware, and software. We are a one-stop shop for all your assay development needs.
When using our products for commercial use, such as resale, repackaging, developing, and manufacturing assays for end customers, we grant commercial rights. Our team makes it seamless to obtain commercial rights.
When partnering with our OEM team, we bring leading regulatory affairs, legal, and financial experts to support submission, approval, and market launch.
With more than 50 well-staffed distribution and manufacturing sites, we can offer you an unprecedented level of supply chain security through our far-reaching global footprint and site redundancy, scale-up experience, and financial stability that comes with it.
Click image to enlarge
Figure 3. Snapshot of global distribution centers.
Assurance of quality marked by reduced batch variability and robust quality control testing to help meet regulatory standards.
Accreditations and regulatory compliance*
- ISO 9001, ISO 13485, and ISO 14001 certified quality systems
- US 21 CFR Part 820 Quality System (current good manufacturing practice, cGMP)
- Class I, II, and III medical devices and general-purpose reagent certified manufacturer under USDA guidelines
- US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) registered media production sites
- Select good laboratory practice (GLP) accredited sites
- Readily available and downloadable Certificates of Analysis (CoA) and Certificates of Conformance (CoC)
*Note: Certain regulatory standards are available at specific sites only.
Consult with our R&D experts to set off your project on the right track, execute projects with precision, and troubleshoot projects inflight. Our manufacturing teams have supported a wide range of products across a diverse group of therapeutic and diagnostic focus areas including oncology, infectious disease, cell therapy, agricultural and environmental applications, and food safety.
Execute your unique vision through a wide selection of off-the-shelf and custom manufacturing options and services. These include component alterations, modified reagents, molecular synthesis, novel consumables, custom packaging, and other end-to-end product development.
We have products dedicated to different workflows, technologies, and applications, including raw materials, reagents, instruments, hardware, and software. We are a one-stop shop for all your assay development needs.
When using our products for commercial use, such as resale, repackaging, developing, and manufacturing assays for end customers, we grant commercial rights. Our team makes it seamless to obtain commercial rights.
When partnering with our OEM team, we bring leading regulatory affairs, legal, and financial experts to support submission, approval, and market launch.
With more than 50 well-staffed distribution and manufacturing sites, we can offer you an unprecedented level of supply chain security through our far-reaching global footprint and site redundancy, scale-up experience, and financial stability that comes with it.
Click image to enlarge
Figure 3. Snapshot of global distribution centers.
Focus areas of OEM solutions
- RT and PCR enzymes
- Restriction and modifying enzymes
- Isothermal amplification
- Thermal cyclers and PCR plastics
- Custom oligos
- Sample preparation
- Enzymology
- Protein analysis
- Cell culture
- Labeling and detection reagents
OEM solutions for molecular diagnostics
Discover our solutions and services for raw materials used in molecular diagnostics.
View lyophilization- and microfluidics-compatible enzymes for point-of-care diagnostics.
Eliminate problems encountered with filter-based nucleic acid isolation methods with bead-based solutions.
OEM solutions for immunodiagnostics
Check out our wide range of capture surfaces including magnetic beads, latex beads, and surface-coated multi-well plates.
Explore our extensive line of antibodies includes primary and secondary antibodies conjugated to the wide array of fluorescent and enzymatic labels, as well as a comprehensive portfolio of thousands of ELISA products.
Check out our bioconjugation products including, crosslinkers, PEGylation, biotinylation, and labeling reagents that connect capture surfaces to antibodies, and antibodies to enzymes and dyes used with detection technologies.
We offer a wide range of traditional enzymes in glycerol buffer and lyo-ready enzymes that can be used in your kits, bulk supply for fill and finish, custom packaged and labeled to your requirements.
Read more about of our OEM reagents services
Enzyme selection guide for OEM services
OEM and commercial supply FAQs
Our team has established an impressive resume of scale-up processes due to the substantial production cycles they have already successfully completed for several products. This experience gives them a better bird’s-eye view of the path to production at larger scales without sacrificing quality. With better expectations and planning, our scale-up manufacturing efforts are often incredibly efficient compared to other organizations. Leveraging our experience in scaling up our own products, and those of partners, we can apply our well-earned knowledge to minimize the risk for your product.
While manufacturing experience is a clear focus for our work and teams, it is not the only type of experience we bring to our partnerships. Bringing a product to market requires much more than just making or assembling the product—it also requires know-how to navigate regulatory, legal, and financial elements. When partnering with our OEM supply and commercialization teams, we also bring leading regulatory affairs, legal, and financial experts to support submission, approval, and market launch. Importantly, your devoted commercial supply business development manager (BDM) will serve as your internal project champion to fully connect our entire team and yours.
Your devoted commercial supply business development manager (BDM) will serve as your internal project champion offering support and training through every step of your processes, with countless combined years of experience.
For life science product developers, the trouble starts when a key supplier runs into issues beyond their control, like starting material shortages, increased reagent demand, regulation changes, civil unrest, economic downturn, natural disasters, and disease outbreaks. In truth, it is remarkably difficult to fully insulate your product development from supply chain challenges without comprehensive standing infrastructure that can be quickly mobilized. This is where Thermo Fisher Scientific stands alone in our ability to support our partners.
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