OEM & Commercial Supply

 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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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:

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.

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.

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.