Custom GMP-Grade 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 GMP-Grade Oligos.
Custom cGMP Oligos
Place your order directly with the manufacturer.
As part of our Custom Oligos for Commercial Use offering, our Custom GMP-Grade 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 GMP-Grade Oligos is our suite with three laboratories: Synthesis, Purification, and Quality Control. The following applies:
- 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 & documented 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 GMP-Grade Oligos
This brochure introduces Merck’s Custom GMP-Grade Oligos offering, designed to support molecular diagnostics (MDx), laboratory-developed tests (LDTs), and preclinical research. Manufactured within a dedicated facility operating under an ISO 13485-certified quality management system and ISO 14644-1 Class 8 cleanroom conditions, the oligonucleotides are produced using controlled and documented processes to ensure traceability, consistency, and reproducibility.
The brochure details manufacturing capabilities for custom DNA oligos, qPCR probes, and next-generation sequencing (NGS) oligos, as well as available purification options, modifications, quality control tests, and scale-up support. It also highlights the importance of supplier qualification, documentation, manufacturing capacity, and regulatory compliance when selecting a GMP oligonucleotide partner.
Resource details
- Resource type: Product brochure
- Page count: 8
- Read time: 14 mins
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.
Resource details:
Resource type: Product brochure
Page count: 8
Read time: 12 mins
Contrast in oligonucleotides
This resource compares Research Use Only (RUO) and GMP-grade oligonucleotides, highlighting key differences in quality management systems, manufacturing locations, instrumentation, purification methods, production scales, lead times, and intended applications. It shows how RUO oligos are primarily designed for basic research and R&D activities, while GMP-grade oligos are intended to support scale-up, preclinical research, and commercialization.
The resource also outlines the products available in each category, including DNA oligos, RNA oligos, probes, sequencing oligonucleotides, siRNA and miRNA products. Additionally, it details the quality assurance frameworks supporting each offering, including ISO 9001, ISO 13485 and cleanroom manufacturing requirements.
Resource details
- Resource type: Scientific poster
- Page count: 1
- Read time: 2 mins
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.
