Custom GMP-Grade Oligos

2 Jul 2026

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

Custom GMP-Grade Oligos

Merck

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.

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OligonucleotidesOligonucleotides are small nucleic acid polymers, usually less than 20 bases in length. Oligonucleotides can be made via enzymatic cleavage or more commonly by chemical synthesis with polymerases. Their use includes FISH, southern blots, microarrays and as primers in PCR. High fidelity synthesis kits and detection systems are available for easy production and detection, respectively.Molecular DiagnosticsMolecular diagnostics use an individual’s genetic code and gene expression to diagnose and monitor diseases. The technique is used increasingly in the field of infectious diseases and oncology, as well as areas such as coagulation, HLA typing and pharmacogenomics. Molecular diagnostics plays a pivotal role in personalized medicine.qPCRQuantitative PCR (qPCR) is a molecular biology technique used to amplify and measure the amount of a specific DNA or RNA target. It plays a crucial role in gene expression analysis, pathogen detection, and quantifying DNA or RNA in various applications. Real-time PCR provides precise, quantitative results and is widely used in research, diagnostics, and clinical studies. Browse our peer-reviewed product directory to find the best qPCR solutions; compare products, check reviews, and get pricing directly from manufacturers.NGS