At our GMP facility, we customize our workflows to meet the MDx customer needs
Consistency and reproducibility. ISO & FDA facility
You don't need a supplier, you need a support system.
You are about to embark on an exciting journey to develop an assay, kit, or commercial product that will improve peoples lives. It will be exhilarating but also stressful. and Eurofins Genomics is here to alleviate that stress. We are the partner that will go the extra mile to make your assay perform to its highest level.
Whether targeting the PCR, NGS, or qPCR market, the research phase is a critical period which heavily impacts your success later. Choosing the right supplier early in your journey is key. Eurofins Genomics offers the flexibility you need during the research phase to test and perfect your sequence design, so that your MDx application performs optimally. Furthermore, our exclusive synthesis technology produces the highest grade oligos available, faster than any other supplier, giving you a head start.
The research phase focuses on sequence design and validating that the assay performs well in functional testing. Fast turnaround, quality, and cost are key.
MDx companies begin ramping up and testing lot-to-lot variability. Consistency and reproducibility are key.
Production and lot size must ramp up to full capacity. Custom packaging and kitting needs are complete. Turnaround time extends into long-term forecasts.
Speed is critical in order to be first to market. Eurofins Genomics is the fastest oligo provider in the world.
Eurofins Genomics proprietary purification method, HPSF, offers Dx customers a more cost effective path to reach the purity they need and cost model.
Consistency in quality, concentration, and volume are key throughout the process because the oligos determine the performance parameters of your experiment, such as the detection limit and specificity of your assay. Eurofins Genomics QC checks every order before it leaves our facility to ensure the end product is consistent.
Large suppliers are attractive due to their capacity, but struggle with customization. Their manufacturing floor is based on high throughput, not flexibility. This greatly impacts the research phase, wherein MDx customers are still designing sequences and need to make adjustments quickly. Eurofins Genomics offers a balance of both capacity and customization. Our cGMP facility contains a wide assortment of equipment, giving us the ability to drill down or ramp up quickly.
As MDx companies ramp up for a commercial launch, they need lot-to-lot reproducibility to ensure the material will perform the exact same way, every time. Variability in lots can affect how the application functionally performs. Eurofins Genomics creates completely separate workflows for MDx customers, depending on volume, to mitigate variability and improve reproducibility.
One of the most important criteria for a large commercial company is batch-to-batch reproducibility so their assay performs exactly the same with each lot. All aspects of our manufacturing process are monitored and documented resulting in a formal batch record. Our QA teams will support your vendor qualifications, paper audits, on-site audits, and the overall product release of GMP orders. In some cases, a certificate of analysis must be signed before the product can be released by the QA team.
Eurofins Genomics documents all aspects of an order as it flows through our state-of-the-art facility, which allows us to track the order and changes throughout the production process.
Traceability is key for regulatory purposes and audits. Eurofins Genomics uses a parallel system of both digital and print records to trace what was done on each order.
Eurofins Genomics prides itself on open, intelligent discussions between both parties, whether it relates to optimization, troubleshooting, or unexpected hurdles.
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