Processing
RUO or GMP oligos?
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?
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 each customer complete process transparency and product traceability.
RUO vs. GMP manufacturing
RUO | GMP | |
|---|---|---|
| Objective | Provide oligos for RUO in the shortest turnaround time possible at competitive market prices Provide clinical grade or commercial use oligos with customer-defined and controlled processes | 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 9001:2015 (emphasis on continuous improvement) | ISO 13485:2016 (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 |
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