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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. A solid partnership is the bedrock of successful commercialization strategy—can help make it to market with speed and precision and without the stress and costs associated with do-it-all on your own.
Our commercial supply team specializes in helping you bring your solutions to market faster. Connect with our team and learn how we can support your next groundbreaking project with reagents and consumables, instruments, and custom kit package solutions.
OEM solutions and services
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 and Figure 2 outline services that help enable you to scale up production and take your product to market.
Figure 1. OEM process overview: From concept to commercialization.
Figure 2. Snapshot of OEM services.
OEM solutions and services: Focus areas
OEM solutions and services that cater to specific focus areas are listed below.
- Restriction/modifying enzymes
- Enzymes for RT and PCR
- Custom oligos
- Thermal cyclers
- PCR plastics
- Products for cloning
Molecular diagnostic test developers
Restriction/ modifying enzymes, enzymes for RT & PCR, custom oligos, Thermal cyclers, PCR plastics, cloning
- Antibodies
- ELISA reagents
- Bioconjugation
- Detection substrates
- Sample preparation
- Enzymology
- Protein analysis
- Cell culture
- Labeling and detection reagents
OEM instruments
To bring your clinical assay to market on an instrument that is commercially available in the market, we offer OEM instrument partnerships which allows instrument placement in a rental program or private label the instrument.
OEM reagents
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
Advantages of Thermo Fisher Scientific OEM solutions
Thermo Fisher Scientific OEM solutions encompass a suite of products and services.
Figure 3. Partnership opportunities for commercialization of life science products.
Quality
Assurance of quality marked by reduced batch variability and robust quality control testing to help meet regulatory standards.
Accreditations and 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
Resources and expertise
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.
Customization
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.
Workflow solutions
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.
Access to commercial rights
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.
Partnership
Partner with us to convert your ideas to products that reach the end-user. Bringing a product to market also requires know-how to navigate regulatory, legal, and financial elements. When partnering with our OEM supply and commercialization teams, we bring leading regulatory affairs, legal, and financial experts to support submission, approval, and market launch.
Security of supply
Figure 4. Snapshot of global distribution centers.
We have strategically invested in building and acquiring new manufacturing sites, distribution centers, production equipment, and scientific talent to provide high-quality raw materials and commercial services wherever and whenever needed.
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.
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.
Resources
Webinars
Case studies
For Research Use Only. Not for use in diagnostic procedures.
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