GMP probes and primers

GMP probes and primers are an extension of our PrimeTime^® products. The GMP versions are manufactured under GMP conditions and are suitable for use in clinical and molecular diagnostic applications. Using the GMP Oligo Entry tool, you can design your probes and primers to contain the exact sequences and modifications you need. You can also specify purification and formulation options. With GMP probes and primers, you can alleviate unknown or undefined regulatory burdens involved with LDT and IVD applications to transition from research to commercialization more efficiently.

Freedom™ Dyes for affordable diagnostics

Among the many modifications available to you through the GMP Oligo Entry tool are Freedom Dyes. These fluorophores include no patent licensing restrictions from IDT or third-party companies. Freedom Dyes include FAM, HEX, JOE, MAX, TET, ROX, and TAMRA. Freedom ATTO™ dyes are particularly good substitutes for VIC^®, LIZ^®, and Alexa Fluor^® dyes due to their strong absorption and sensitivity, enhanced photostability, and high fluorescence quantum yield. Learn more about Freedom Dyes.

Analyte-specific reagents (ASRs)

The US FDA defines ASRs as antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. If your work requires such reagents, you can add ASR labels to your oligos using the “Services” menu in the GMP Oligo Entry tool.

IDT has long been a leader and pioneer in custom oligo manufacturing. This is largely due to our vertically integrated proprietary synthesis platform, of which nearly every component is developed in-house. By managing most of the machines, reagents, and automation systems we use to manufacture your oligos, we can precisely monitor and refine our systems to provide you with the highest quality.

Legal and regulatory guidance

A quality GMP team should help you manage the regulatory and legal burdens that exist in the diagnostic space. Our facilities are ISO 13485:2003 certified and compliant with US FDA Quality System Regulation 21 CFR, Part 820. We maintain an “open door” audit policy.

Common regulatory solutions include:

• On-site product or process audits with our Quality Assurance team
• Validation programs for all equipment and processes
• A rigorous product-release process managed by our Order Verification and Release team

Brochures and flyers

PrimeTime^® Predesigned qPCR Assay Database

Selects qPCR primers and probe sequences for human, mouse, and rat gene expression assays

PrimerQuest^® Tool

Allows highly customized designs for PCR primers and qPCR assays

RealTime PCR Tool

Selects custom qPCR assays for any species

Manufacturing process and traceability

When you order GMP-manufactured oligos from IDT, you receive the highest standards of traceability. The controlled and validated process is governed by the Oligo Master Record (OMR)—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:

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

Legal and regulatory guidance

A quality GMP team should help you manage the regulatory and legal burdens that exist in the diagnostics space. Our facilities are ISO 13485:2003 certified and compliant with US FDA Quality System Regulation 21 CFR, Part 820. We maintain an “open door” audit policy.

Our common regulatory solutions include:

• On-site product or process audits with our Quality Assurance team
• Validation programs for all equipment and processes
• A rigorous product-release process managed by our Order Verification and Release team

OEM services »

You can obtain our industry-leading synthesis technologies, manufacturing capabilities, and technical expertise as a comprehensive third-party OEM service. 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 at GMPinfo@idtdna.com or call 800-328-2661.