Oligonucleotide-based drugs are transforming modern medicine, offering targeted treatments for genetic and rare diseases, but their complex chemistry brings new analytical challenges and regulatory expectations.
At Kymos Group, we provide a comprehensive suite of quality control and CMC analytical services for synthetic oligonucleotides, supporting our clients from early development through GMP release testing.
These services build on the analytical methods developed during OligoXplorer, our in-house research initiative dedicated to advancing oligonucleotide characterization, and are now fully validated and available to industry partners.
SERVICES
Our Analytical Capabilities
| Quality Attribute | Parameters | Techniques |
|---|---|---|
| Strength | Assay, lipid content in LNP | Ion Pair-HPLC-UV-MS, HPLC-CAD |
| Identity | Sequence, molecular weight, chemical structure, lipids, sodium | Ion Pair-HPLC-UV-MS, AEX (SAX)-HPLC, NMR, HPLC-CAD, DLS, ICP-MS |
| Purity | Aggregation, product-related impurities, residual solvents, acetate, water content, elemental impurities | SEC-HPLC, Ion Pair-HPLC-UV, AEX (SAX)-HPLC, HS-GC, KF, Ionic HPLC, ICP-MS |
| Safety | Bioburden (TAMC/TYMC), endotoxins, sterility | Microbiology techniques |
| Compendial | Appearance, osmolarity, particulate matter, pH, extractable volume | Standard techniques |
Formulation & Complementary Tests
To provide a complete analytical picture, we also perform complementary studies in-house and through established partnerships:
- Lipid quantification in LNPs by HPLC-CAD.
- Residual solvent and buffer analysis, including sodium acetate content.
- Elemental impurities testing by ICP-MS.
- Particle size, aggregation state, and polydispersity by DLS.
- Bioburden, endotoxins, and sterility by microbiology techniques.
Why Choose KYMOS Group?
Services
Related services to QC of Oligonucleotides
Bioanalysis of Nucleic Acids
Quantification of nucleic acids as therapeutics, biomarkers, or similar with standardized and reproducible methods according to GLP.
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