Partner with momentum and advance your product
Organizations developing diagnostic, therapeutic, and life science products must continually innovate and produce increasingly sophisticated offerings to support vital efforts in basic research, drug discovery, clinical testing, and beyond.
Just as important as the powerful ideas behind your product are the commercial partnerships you form to bring those ideas to market. The success of your work often depends on having a manufacturing and commercial supply team in your corner that can deliver repeatedly and sustainably, regardless of outside factors.
You know that access to high-quality raw materials, secure supply chains, and know-how through tested experience are extremely valuable to commercial development. Naturally, you want a commercial partner that can deliver these advantages reliably and routinely, especially in an increasingly complex scientific environment and uncertain world.
By all accounts, Thermo Fisher Scientific is that partner for a multitude of organizations creating life-changing products that break new scientific ground and advance our collective well-being. Through strategic investment and constant research and development, we have built significant momentum that accelerates innovation and commercialization to the benefit of our partners, big and small.
Sourcing success and solving challenges with the full weight of Thermo Fisher Scientific behind you
With Thermo Fisher Scientific’s Original Equipment Manufacturer (OEM) and Commercial Supply team, our partners gain access to the tremendous resources and knowledge we’ve assembled through a track record of successful partnerships and in our role as a world-leading scientific organization.
Our consistent success begins with an expansive portfolio, from which you can source key elements needed to construct your product. This portfolio encompasses a wide selection of:
Raw materials and reagents including:
- OEM enzymes, antibodies, custom recombinant proteins
- Phosphoramidites, nucleotides, oligonucleotides, and PCR primers and probes
- Nucleic acid extraction and purification reagents
- Capture surfaces and magnetic beads
- Dyes, labels, and linkers
- Buffers, detergents, and substrates
- Animal origin-free reagents
Plastics and consumables including:
- PCR/qPCR and ELISA plates
- Gibco cell culture plastics
- Nalgene labware
- Tubes, seals, bottles, vials, and more
- PCR thermal cycling and real-time PCR
- Next-generation sequencing
- Capillary electrophoresis
- Microarrays and analysis
- Workflow automation
Custom kitting and OEM packaging solutions including:
- Custom fill volumes
- Buffer, master mix, nucleic acid, protein, and enzyme formulations
- White labeling
- Complete assay kitting
In addition to accessing our broad product portfolio, a partnership with Thermo Fisher Scientific also ensures success through our effective and well-demonstrated problem-solving. We’ve seen firsthand that every project has its own specific challenges, but significant infrastructure and a scholarly approach to manufacturing go a long way towards circumventing and overcoming both common and one-of-a-kind problems. To this end, Thermo Fisher Scientific’s expansive worldwide network of sites are populated with research-oriented manufacturing scientists who leverage their previous learnings to quickly identify and resolve issues.
Our team is devoted to ensuring clear and open communication—an essential aspect of maximizing efficiency and seamlessly solving problems. Our commercialization team will provide immediate points of contact to act as your advocates, devoted to putting the full weight and resources of our world-leading organization behind your project at every step of the commercialization journey.
Don’t just take our word on it, let us prove it to you by discussing the specifics of your project. Talk with a member of our team and find out how we can combine our strengths with yours.
Factors that harness our momentum for your partnership
While there are countless ways that our OEM and Commercial Supply team can harness the full weight of Thermo Fisher Scientific for your product’s benefit, we see four factors as being the most critical to success. For us, it all starts with elevating your product with an ever-present attention to quality. Naturally, it is equally important to always deliver those high-quality materials and products safely and on-time with world-leading supply chain security. Plus, your ground-breaking life science product will almost certainly need customized solutions to bring its one-of-a-kind potential to market. Finally, our team’s impressive diversity of experience pulls it all together and minimizes project risk through creative and critical thinking.
For more information, read further about how our commitments to superior quality, secure supply chains, fit-to-purpose customization, and ever-expanding expertise accelerate our partnerships.
Quality elevated for commercial supply
Ensuring you have complete control over the quality of your raw materials and packaging is essential to avoiding unexpected challenges and product failures. Given that every product and its applications are different, you need a commercial partner that goes beyond a one-size-fits-all approach to quality control.
At Thermo Fisher Scientific, we have practiced and refined quality control—in both our own products and those of our partners—for decades. Through this accomplished approach, we have learned that for quality control to be most effective, it shouldn’t be treated as a discrete step of manufacturing—it must be baked-in throughout the entire process. Working with Thermo Fisher Scientific, your materials and products will be manufactured using the same infrastructure and processes used to make our own products. This means that the world-class quality our products are known for can be transferred directly to our partners for their benefit.
We can leverage our experience to deliver the quality your product needs while using our Six Sigma and Lean manufacturing processes to manage and optimize costs. For more on our quality philosophy, read about how a personalized approach, advanced quality systems management, global cold chain reach, and innovative analytical testing deliver results for both us and our partners.
Webinar: Product development & regulatory compliance—maintaining quality and compliance
Hear three experts discuss how a phase-appropriate cGMP system can be implemented with regulatory compliance from product development to commercialization.
A personalized approach
With Thermo Fisher Scientific OEM supply, we apply a strategic approach to quality that delivers exactly as needed for your unique product, whether intended for research use only (RUO) or bound for the clinic. While GMP facilities provide the highest level of quality control, we know that the extra rigor they ensure does not effectively serve RUO products. Together we'll determine a scalable quality approach specific to your product's customized needs and requirements. You will be certain that the quality system applied to your product is there to serve its advancement, rather than just a box to check.
Advanced quality systems management
Regardless of which site your product is made at or what level of rigor is applied, you can rest assured that a preeminent and accredited quality management system will be used. We continuously monitor every manufacturing process to secure documented evidence that your specified quality is achieved. We routinely analyze the resulting data to determine the need for improvement activities using the Corrective and Preventive Action System (CAPA). Aside from monitoring, our sites and suppliers are habitually audited to verify that all activities comply with standing quality documentation. In addition to our internal audits of our departments and suppliers, independent certifying bodies (FDA, Det Norske Veritas, etc.) audit our sites, and we welcome additional audits from our partners to build personal confidence in our shared work.
Global reach protected by best-in-class cold chain capabilities
While manufacturing quality is critical, delivering that quality to market is just as essential. With over 50 distribution and manufacturing sites, our global reach helps minimize OEM reagent travel. Importantly, we interconnect our sites and yours using well-established and best-in-class cold chain capabilities, which further protects your product quality and performance. Together, we ensure that every material arrives at its target destination safely, regardless of where on the planet it’s headed.
Reducing batch variability with innovative quality assurance and quality control testing
Superior quality assurance relies on quality control testing to ensure exact specifications of raw materials and reliable analysis of final product batches. With countless testing capabilities and explicit experience measuring a wide number of common and uncommon impurities, Thermo Fisher Scientific is capable and ready to support the most challenging quality control testing needs.
Ensuring quality isn’t a routine analysis to look for only expected products and impurities. We push to apply advanced analytical capabilities to look for previously undetectable levels of impurities and inconsistencies. The combination of our experience in quality assurance and control, with premiere analytical chemistry methods and instrumentation, provides us with the capacity to deeply assess material quality and avoid downstream complications. As a result, we minimize batch variability and increase lot-to-lot consistency so that your raw materials and subsequent product do not differ unexpectedly across production.
Accreditation 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
*Note: Certain regulatory standards available at specific sites only
Far-reaching infrastructure delivers a secure supply chain
While a connected world means that life scientists across the globe can work together to achieve remarkable successes, it also means that the medical and scientific communities are increasingly dependent on distant suppliers that must ship materials and products across borders and oceans.
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 profound standing infrastructure that can be mobilized at a moment's notice. This is where Thermo Fisher Scientific stands alone in our ability to support our partners.
Video: Ensuring security of supply in commercial development
If you are developing a commercial assay, ensuring long-term security of supply is essential.
For decades, we have strategically invested in building and acquiring new manufacturing sites, distribution centers, production equipment, and scientific talent with the aim of ensuring our ability to provide high-quality raw materials and commercial services wherever and whenever needed. With an ever-growing list of more than 50 expertly staffed distribution and manufacturing sites in operation, we can offer you an unprecedented level of supply chain security through our far-reaching global footprint and the site redundancy, scale-up experience, and financial stability that comes with it.
Site redundancy without the cost or effort
The establishment of redundant OEM supply manufacturing sites and scientists represents a primary method by which we can guarantee delivery of raw materials regardless of outside factors. In effect, if a single site is dealing with unforeseen challenges, we can produce and deliver from another location. Furthermore, scientists across these sites can easily and seamlessly collaborate to ensure a smooth transition and timely delivery of OEM reagents. Importantly, you are not paying for this redundancy—it's provided by our inherent scale, allowing you to trust promises made in our supply guarantee agreements.
Scale-up experience and qualified teams
We also secure our supply chains through experienced scientific teams and staff that efficiently run our facilities and pilot cutting-edge equipment. Through their years of delivering on manufacturing targets, these teams have cultivated a wealth of manufacturing science experience that they draw on to solve new and unique challenges. Repeatedly, we have witnessed that past experience lends itself to the development of creative and critical thinking needed to accelerate current projects. During scale-up, this experience pays dividends for our partners. The brilliant teams that power our global site network can draw on personal knowledge and collaboration to find solutions to tricky issues encountered during scale-up. We can confidently reach the required scale for your project, even where others cannot, because we have world-leading teams working as one on your behalf.
Financial resources and stability at our disposal and yours
The other key safeguard to our OEM supply chains is that we have tremendous financial resources that can be applied to acquire key equipment, hire new staff, and even build entirely new sites to further secure supply and fortify future work. Separate from buying power, having a depth of resources on tap helps ensure stability. Thermo Fisher Scientific is here to stay, so our partners will never need to worry about our doors closing and the headache of shifting their supply chain elsewhere.
Customized solutions make for one-of-a-kind products
When commercializing a scientific product aimed at addressing an unmet need, you’re often riding a field’s cutting edge. This means that to really break new ground, you need to provide a product that stands apart and that's one-of-a-kind. It’s nearly impossible to do this without addressing unique needs via custom solutions.
The OEM & Commercial Supply team at Thermo Fisher Scientific can help you execute your unique vision through a wide menu of custom manufacturing options and services. These include simple component alterations, modified reagents, molecular synthesis, novel consumables, custom packaging, and everything in between. Our manufacturing scientists are ready to discuss your individual project and the needs required to turn your concept into a packaged product. If our extensive suite of manufacturing solutions doesn’t address your specific project needs, we can always find a custom solution that fits.
To articulate some of our custom solutions, consider the customization options and examples below.
General services and common alterations:
- Fill volume changes
- Aliquoting for single use or kitting
- Concentration variations
- Bulk ordering
- Custom formulations (including lyo-ready enzyme formulations)
- Animal origin-free reagent supply
- Linker, label, dye, and fluorophore functionalization
Reagents and raw materials:
- Amidite/phosphoramidite preparations
- qPCR grade dNTPs, NTPs, and modified nucleotide solutions
- Custom buffer manufacturing
- Modified BSA, synthetic blockers, and custom blocking solutions
- Custom detergent and substrate solutions
- Custom OEM beads with options for
- Coupling to biomolecules or bio-reactive ligands
- Chemical group and surface functionality
- Iron content and magnetic characteristics
- Bead size, polymer, and pore structure
- Custom oligos and modified oligos
- mRNA synthesis
- Custom protein and enzyme development using molecular evolution
- Custom protein and enzyme production
- Novel bioconjugation (including crosslinkers, biotinylation, PEGylation)
- In vitro translation (IVT) biosynthesis and IVT enzymes
Plastics and consumables:
- Custom plastic and consumables design
- Product testing and quality control
- Scale production of unique plastics
- Surface functionalization
Custom OEM instrumentation and rebranding:
- Tailored workflow automation support
- Software and UI customization (including branding)
- Custom enclosures and color changes
- Aftermarket services
Assay development and product analysis services:
- Workflow and assay design
- PCR/RT-PCR/qPCR, NGS, capillary electrophoresis, ELISA, western blotting, microarrays, and more
- Purification optimization
- Performance testing
- Bridging studies
- Verification and analytical validation testing
- Stability studies
Video: Collaboration in molecular diagnostics enzyme development
Collaboration in development of lyophilization-compatible Taq DNA polymerases and SuperScript III RTs, with the same high performance as the conventional formulation.
Video: Custom oligos
Providing custom DNA oligo synthesis products and services with superior quality, quick turnaround time, and affordable prices.
Minimizing risk through diversity of experience
As you explore potential partnerships with commercial suppliers, there’s no doubt you are looking to collaborate with experience. That said, experience comes in a wide variety of depths, processes, and focus areas. For this reason, general manufacturing experience alone is not always enough to fully mitigate project risk and downstream challenges. Often a diversity of experience ends up making the largest difference.
A standout feature of Thermo Fisher Scientific’s commercial manufacturing and OEM supply team is the profound range of experience that we've accumulated to pair with our unmatched depth of knowledge. The many individuals distributed throughout our sites are industry-leading manufacturing scientists with countless combined years of experience, producing all manner of life science raw materials, reagents, and products. This collection of talent has faced and completed a diverse set of manufacturing projects, which enables them to predict roadblocks ahead of time and more quickly resolve issues through creativity.
Critical therapeutic and diagnostic focus area experience
Our manufacturing experience has supported a growing number of products across a diverse group of therapeutic and diagnostic focus areas. Below, find a select list of focus areas our teams are well established working within:
- Infectious diseases
- Reproductive health
- Cardiovascular studies
R&D builds deeper experience across a wider skillset
At Thermo Fisher Scientific, our manufacturing teams never stop learning and growing their skillset. While some of our learnings come from specific partner projects, our continued investment into our own research and development of manufacturing processes massively fortifies our experience. This means that while executing collaborative projects with our partners, we are also actively exploring how we can continue to improve our quality and yields. These R&D efforts also focus on new methods and advanced techniques to achieve desired outputs for both us and our partners. Since the value of R&D is core to our beliefs as a leading life science and research tools company, our R&D learnings continually add to our abilities at no cost to you.
As an example, check out this video to hear how our cutting-edge molecular evolution capabilities have already made impressive returns for our diagnostic clients.
Video: Molecular evolution in molecular diagnostics enzyme development
Utilizing molecular in vitro evolution to engineer performance improvement in enzyme function for development of low-DNA contaminant PCR and RT enzymes.
Scale-up experience reduces risks as you grow
As most know, manufacturing scale-up is quite sophisticated and often more involved than initial predictions. Our team has established an impressive resume of scale-up processes due to the substantial production cycles they have already successfully completed for a number of 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.
Regulatory, legal, and financial expertise
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. The combination of vast manufacturing experience with these additional skill sets has provided comfort and assurance to clients that often translates to significant praise from regulatory bodies and investors alike.
“The broad range of genetic analysis products, including Ion Torrent™ next-generation sequencing instruments, is only one of the many reasons we chose Thermo Fisher Scientific as our strategic partner for developing molecular diagnostic tests. Its dedicated team—including field engineers, bioinformaticians, key account managers, CFDA registration experts, and global leaders—has been a great resource in helping us expand our business.”
– Junquan Xu, President, CapitalBio Technology
“Securing access to Invitrogen™ Dynabeads™ MyOne™ magnetic beads and reagents for our second generation colorectal cancer blood test enabled us to reduce the complexity of the kit significantly. The high-quality materials were able to improve reproducibility and robustness of our method.”
– Uwe Staub, PhD, Chief Operating Officer, Epigenomics
“Adding the Applied Biosystems™ QuantStudio™ 5 Real-Time PCR System to the VERSANT™ kPCR Molecular Solution brings a new level of innovation to the market by providing more flexibility and customization to the molecular laboratory workflow. We are excited to strengthen our dedication to molecular laboratory innovations through our partnership with Thermo Fisher Scientific.”
– Fernando Beils, Head of Molecular Diagnostics, Siemens Healthineers
“The quality and performance of Applied Biosystems™ master mixes and custom oligos are key for our diagnostic kit development. The Thermo Fisher team provided us with a one-stop solution for the entire process—from assay test design, assay optimization, and kit validation, to partnering on the development of our commercialization strategy.”
– Patrick Burke, PhD, Executive Vice President, Emerging Products, Myriad Genetics
“The relationship with Thermo Fisher Scientific secures our access to customized material essential for the manufacturing and commercialization of our RNA-based product candidates. In addition, as a life science services leader, Thermo Fisher can also deliver reagents at the scale needed to expand our manufacturing capacities.”
– Ugur Sahin, M.D., co-founder and CEO of BioNTech