GMP Oligonucleotide Manufacturing for Molecular Diagnostics

Oligonucleotides for In Vitro Diagnostic Devices (IVDs) or Analyte Specific Reagents (ASRs) for Laboratory-Developed Tests (LDTs)

IDT GMP Manufacturing of Custom Oligos for in vitro Clinical Diagnostics

Custom Oligos for in vitro Clinical Diagnostics

  • Facilitated progression from research to commercialization
  • Customer-defined and controlled manufacturing process
  • Flexible ordering methods - order in the units that work best for you
  • Deliverable yields from 10 nmoles to multiple grams
  • Long-term pricing stability available through supply agreements

Minor Groove Binder (MGB) Eclipse® Quenched Probes

  • For use as components in human in vitro diagnostic (IVD) applications

Customize the Manufacturing Process for Your Oligos

Oligo Master Record sample

Design, approve, and audit your comprehensive production plan with our Oligo Master Record.

IDT custom manufacturing processes are driven by customer needs, with consultation from our scientists:

  • Guidance in transition from small batch to large scale production
  • Harmonized purity specifications and analytical methods
  • Customer dedicated purification columns available
  • Choice of aliquoting and vialing formats
  • Ability to provide custom oligo mixtures

IDT offers a full range of final-fill, labeling and OEM solutions with services including:

  • Customer-specified concentration formulations
  • Custom packaging
  • OEM and kitting solutions
  • Third party labeling
  • Plate packaging
  • Stability programs
  • Functional QC

Minimize Regulatory and Legal Burdens

Our facility is FDA registered (3004613294) and ISO 13485:2003 certified.

IDT provides:

  • Independently verified product compliance and release prior to shipment (Certificates of Analysis).
  • Hardcopy analytical QC documentation as a standard product offering
  • Quality agreements/contracts
  • Validation programs for all equipment and processes

IDT has an open door audit policy.

Specify Your Ordering Processes

A dedicated GMP Manufacturing Customer representative is assigned to your account and serves as a single point of contact, coordinating all activities from order entry to final delivery:

  • Place your orders directly with your representative. Workflow is verified with manufacturing for accuracy prior to production.
  • We can quote GMP Manufacturing pricing per customer-defined unit of measure (e.g., per nanomole, per aliquot, per kit, etc.). This feature eases inventory planning and supply forecasting, provides consistent delivered quantity per lot, and allows order by predefined part number.
  • "We will learn to speak your language” to facilitate and improve purchasing and inventory management. GMP quotes pricing and communicates in customer supplied ordering units of measure, such as: “X tests”, “X reactions”, “X tubes”. 

Obtain Long Term Stable Pricing Through Supply Agreements

  • Pricing is typically fixed for 3-5 years, with static pricing guarantees tied to purchasing forecasts.
  • Incentive discounts (based on purchasing milestones) are common.
  • OMRs, forecasts, lead times, and “Quality Agreement” language are all integrated into one, definitive agreement.

Contact Us

Email gmpinfo@idtdna.com
Email your Sales Representative
Or call 800-328-2661
About GMP Manufacturing at IDT

Our GMP Manufacturing services include dedicated ordering, production, final-fill, and shipping systems that meet the elevated quality standards required for products in clinical or commercial applications. ISO 13485:2003 certified, compliant with US Food & Drug Administration (FDA) Quality System Regulation (QSR) 21 CFR Part 820, and facility registered with FDA, IDT is a contract GMP manufacturer of oligonucleotide reagent components for in vitro diagnostic devices (IVDs) and analyte-specific reagents (ASRs) for laboratory-developed tests (LDTs).