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Standard or GMP oligos?

If you are currently using standard oligos from IDT, here are some important considerations when determining if it’s time to transition to our GMP oligos:

  • Are you conducting research with oligos that have a specific diagnostic endpoint?
  • Are you validating research results in preparation for diagnostic commercialization?
  • Are you interested in converting customers with "research use only" restrictions to oligos manufactured and labeled for diagnostic use?
  • Do you need change notification or change approval for your oligo synthesis, purification, or formulation methods?

The GMP business unit at IDT is dedicated to the manufacture of oligos used in molecular diagnostic applications. The range of products and services offered are ideal for customers who have strictly defined specifications or require control over manufacturing processes. IDT GMP products parallel our established, high-quality tools for research and provide customers the opportunity for a simple transition from research to clinical applications.

Standard vs. GMP manufacturing

Standard
GMP
ObjectiveObjective Provide oligos for research use only (RUO) in the shortest turnaround time possible at competitive market prices Provide clinical grade or commercial use oligos with customer-defined and controlled processesProvide clinical grade or commercial use oligos with customer-defined and controlled processes
Manufacturing processAutomation dependent; high throughputValidation dependent; lower throughput
ISO certificationsISO certifications ISO 9001:2008 (emphasis on continuous improvement) ISO 13485:2003 (emphasis on process/change control)ISO 13485:2003 (emphasis on process/change control)
Quality controlESI-MS, OD, CE traces available online; custom reports available by requestHard copy QC traces provided as part of standard GMP documentation packet; customer-defined analytical methods and functional QC testing available

Site tour - IDT B2B capabilities

Take a tour of our facilities and meet key team members within IDT who are involved in the development, support, manufacturing, documentation and commercialization of GMP and OEM products used for in vitro diagnostic (IVD) or life science research applications.

Meet the IDT B2B support team

Meet key members of the B2B support team at IDT and learn how we can help you achieve your goals during the development, manufacturing, validation and commercialization of molecular diagnostic assays or OEM products.