GMP primers and probes

Product details

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.

Quality

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.

Quality Assurance

Our facilities are ISO 13485:2016 certified and can provide custom labeling services for both components and commercial products such as CE marked, ASR, IVD, and GPR. We maintain an “open door” audit policy.

Services

Manufacturing process and traceability

When you order GMP-manufactured oligos from IDT, you receive high standards of traceability. The controlled and validated process is governed by the Device Master Record Index (DMRI)—our collaborative playbook for how we produce your oligos every time you order.

When working with our GMP team, you can define and monitor all aspects of your product’s manufacture. As a GMP customer of IDT, you will have access to:

• LIMS batch records with every order
• Hard-copy analytical QC documentation on every product
• Long-term quality agreements and contracts to ensure a stable supply of high quality GMP oligos

OEM services »

You can obtain our industry-leading synthesis technologies, manufacturing capabilities, and technical expertise as a comprehensive third-party custom contract manufacturing service. You can have custom-formulated products with your own labels and packaging shipped directly to your customers.

Request a consultation

Our team of experts is happy to meet with you to discuss any questions or special requests you may have. Reach us anytime using the IDT Help Request Form.