Processing
RUO or GMP oligos?
The GMP business unit at IDT is dedicated to the manufacture of oligos used in your 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 each customer complete process transparency and product traceability.
Overview
If you are currently using oligos for research use only (RUO) 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?
RUO vs. GMP manufacturing
RUO | GMP | |
|---|---|---|
| Objective | Provide oligos for RUO quickly and at competitive market prices | Provide clinical grade or commercial use processes |
| Manufacturing process | Automation dependent; high throughput | Oligo master record (OMR) define procedures; can follow IDT standard processes or be customized. |
| Quality control | ESI-MS, OD, CE traces available online; custom reports available by request | Hard copy of QC traces provided as part of standard documentation packet; customer-defined analytical methods and functional QC testing available |
Resources
GMP refers to products manufactured under ISO 13485: 2016 QMS. Purchaser is solely responsible for all decisions regarding the use of these products and any associated regulatory or legal obligations for their legal marketing.
RUO22-1164_001