Know the difference between RUO and cGMP oligos
28 Mar 2024Research-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.
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Custom cGMP Oligos
MerckIf 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.