Custom cGMP Oligos
If you commercialize Molecular Diagnostics (MDx), create Laboratory Developed Tests (LDTs), or conduct preclinical research, then your final kit, assay, or modality must have an extraordinary level of quality to comply with strict regulatory or study standards. In the case of oligonucleotide raw materials available with custom specifications, the only option you should consider is Custom cGMP Oligos.
Custom cGMP Oligos
Place your order directly with the manufacturer.
As part of our Custom Oligos for Commercial Use offering, our Custom cGMP Oligos come with consistency and the highest quality. Whether you want to commercialize or develop an assay around qPCR, isothermal amplification, NGS, or other technology, our products strike the right balance between breadth and depth.
The foundation of Custom cGMP Oligos is our suite with three laboratories: Synthesis, Purification, and Quality Control. The following applies:
- Products are manufactured in accordance with US GMP (21 CFR 820)
- Products are filled in classified cleanroom ISO 14644-1:2015 Class 8
- Site maintains ISO 13485 Quality Management System certificate
Benefits of oligos made under these quality and manufacturing systems include:
- Controlled & validated processes
- Extensive materials traceability
- Batch-to-batch consistency
- Reproducible results
- Bulk amounts
Manufacturing oligos in this suite maximizes risk mitigation by minimizing the probability of contamination, mix-ups, deviations, failures, and other errors, which in turn ensure that the oligo products meet the stringent requirements of MDx, LDTs, and preclinical research.
