Time to go GMP?

Whether in research or Dx commercialization, IDT can help you reach your goals

Learn how GMP manufacture of oligos for diagnostic use can provide your organization with defined specifications and control over manufacturing processes.

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
Objective 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 processes
Manufacturing process Automation dependent; high throughput Validation dependent; lower throughput
ISO certifications ISO certifications ISO 9001:2008 (emphasis on continuous improvement ISO 13485:2003 (emphasis on process/change control)
Quality control ESI-MS, OD, CE traces available online; custom reports available by request Hard copy QC traces provided as part of standard GMP documentation packet; customer-defined analytical methods and functional QC testing available

For more information about how our GMP products and services can advance your clinical diagnostic capabilities, visit www.idtdna.com/gmp, or start the process with a free consultation.

Published Jun 17, 2011
Revised/updated Oct 18, 2016