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.
Brochures
Custom cGMP Oligos
In this product brochure, Merck demonstrates its Custom Oligos for Commercial Use offering, for use in molecular diagnostics, laboratory developed tests, and preclinical research.
Contrast in oligonucleotides
In this product brochure, discover the differences between Sigma-Aldrich® oligonucleotides: Research-Use-Only (RUO) and current good manufacturing practice (cGMP, manufactured in accordance with US GMP 21 CFR 820).
Maximize risk mitigation with custom cGMP oligos
Manufacturing oligonucleotides under cGMP 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 molecular diagnostics, laboratory developed tests, and preclinical research. In this brochure, Merck highlights the benefits of custom oligos made under these quality and manufacturing systems such as controlled processes, extensive traceability, batch consistency, reproducible results, and scalability. All products are manufactured in compliance with US GMP standards, utilizing classified cleanrooms and maintaining ISO 13485 Quality Management System certification. Custom cGMP oligos are available with various specifications and modifications for applications such as PCR, qPCR, and next-generation sequencing.
Know the difference between RUO and cGMP oligos
Research-use-only (RUO) oligonucleotides are intended for basic research, R&D, and preclinical research, while current good manufacturing practice (cGMP) oligonucleotides are intended for commercialization. In this infographic, Merck provides information about the differences between oligos for RUO and cGMP oligos and their respective characteristics such as manufacturing, quality assurance, purification, intended use, quantities, institutions, and lead time. RUO oligos are manufactured in accordance with ISO 9001, and cGMP oligos are manufactured in accordance with US GMP 21 CFR 820. The intended institutions for RUO oligos are universities, government agencies, and hospitals, while for cGMP oligos are industrial and testing companies, diagnostic manufacturers, and pharma and biotech companies.
Merck's first cGMP Oligonucleotide Manufacturing suite
In this video, Merck announces the opening of its company's first cGMP Oligonucleotide Manufacturing suite in St. Louis, MO, USA. This expansion broadens their oligo offerings to include cGMP quality oligos tailored for the diagnostic and clinical markets. The benefits of oligos made under these quality and manufacturing systems include controlled and validated processes, extensive materials traceability, batch-to-batch consistency, reproducible results, and bulk amounts.
