GMP primers and probes are manufactured under GMP (Good Manufacturing Practice) conditions and are suitable for use in molecular diagnostic applications. Using the GMP Oligo Entry tool, you can easily design your primers and probes to contain the exact sequences and modifications you need. You can also specify purification and formulation options. With GMP primers and probes, you can alleviate unknown or undefined regulatory burdens involved with IVD applications to transition from research to commercialization more efficiently.
IDT has long been a leader and pioneer in custom oligo manufacturing largely due to our vertically-integrated proprietary synthesis platform, with nearly every component developed in-house. By managing many of the machines, reagents, and automation systems used to manufacture your oligos, we can monitor and refine our systems to provide you with high quality.
Our facilities are ISO 13485:2016 certified and can provide custom labeling services for both components, finished medical devices and commercial products such as CE marked, ASR, IVD, and GPR. We maintain an “open door” audit policy.