It can be difficult to transition a product from research to commercialization. It’s simply not feasible to conduct pilot testing in a fully GMP compliant setting because of the significant costs associated with meeting the FDA’s stringent regulations. To ensure consistency throughout the product lifecycle, IVD developers need to plan from the very beginning to choose component manufacturers who can match both the economic realities and changing regulatory requirements as a product matures.
Biosearch Technologies offers PilotDx™ oligos as a bridge between our custom oligos for research use and our GMP oligos for diagnostic assays. These oligos are ideal for design optimization and verification stages since they are produced using the same equipment, process, and personnel as our GMP oligos. PilotDx oligos have reduced cost and turnaround time compared to GMP oligos because of lower documentation overhead.
If you’re unsure which service is best for your product - custom oligos for research, PilotDx, or GMP oligos, you can request a free IVD consultation session at http://info.biosearchtech.com/IVDconsult/