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Oligonucleotides

Thanks to their potential to reach undruggable targets and their high specificity, therapeutic oligonucleotides (DNA and RNA) are a promising new family of drugs for the treatment of a variety of chronic diseases such as cancer, diabetes, AIDS and cardiovascular conditions. 
 
Due to their relatively large size as compared to typical small molecule drugs, there are many technical challenges associated with the analysis of these molecules. 
 
With a highly experienced staff and state-of-the-art premises and equipment, Quality Assistance is your partner of choice to overcome your analytical hurdles and facilitate the registration process.

 

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Our capabilities in this area are summarized in the following table:

General Quality
Appearance / pH / Osmolarity / Properties after reconstitution  
Particulate matter Optical microscopy / Light obscuration / Imaging Particle Analysis
Water content / residual moisture (if lyophilised) (Coulometry) KF titration
Identity
Intact oligonucleotide (U)HPLC (UV, RI, fluorescence, MS)
Molecular weight ESI-MS / MALDI-TOF
Nucleotide composition / Sequencing UPLC (UV, MSE)
Quantity
Assay UV / (U)HPLC (UV, MS)
Determination of extinction coefficient UV + UPLC (UV)
Purity & Integrity
Purity profile IEX / RP-(U)HPLC / (ic)IEF
Structure Circular dichroism / SEC (UV, RI, ELS, MALLS)
Melting temperature UV
Chain length CE (icIEF), CE-SDS) / IEX / RP-(U)HPLC (UV, MS) / SEC (UV, RI, ELS, MALLS)
Molecular backbone composition (P=S / P=O) IEX
Chemical modifications and degradation patterns
ESI-MS / (U)HPLC (UV, MS) / CGE (UV, LIF, MS) / IEX / RP-(U)HPLC (UV, MS) / SEC-MALLS / IEX / HILIC / SDS PAGE
Aggregation and particle size distribution patterns A4F & SEC-(U)HPLC (UV / RI / MALS) / DLS / Imaging particle analysis
Enantiomeric purity (U)HPLC-UV / GC-MS
Counter-ion content (Mass balance) (U)HPLC (UV, MS) / ICP (OES, MS)
Potency
Immunoassays ELISA / ECL (MSD) / Biacore / FACS
Cell-based assays (Cytotoxicity / Proliferative / Cell death / Cell migration / Cell receptor binding and activation / Reporter gene assays / etc.)
Different readouts
Process-related Impurities
Microbiology Bioburden / Sterility (filtration, direct inoculation)
Endotoxins LAL (kinetic, end point)
Elemental Impurities ICP -MS
Residual solvents HS-GC (FID, MS)
Packaging
Leachables GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS)
Container closure system integrity Bubbling / Dye ingress (methylene blue, fluorescence) / Microbial ingress
Cytotoxicity / Biological reactivity Cell-based assays / USP <87>

 

oligonucleotides-quality-assistance
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