Oligonucleotides

Due to their relatively large size as compared to typical small molecule drugs, there are many technical challenges associated with the analysis of oligonucleotides.

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.

Throughout non-clinical and clinical development, our scientific team provides you with customised solutions in terms of analytical protocols and innovative technologies to help you move your product towards registration.

Your analytical partner providing:

  • customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development

  • a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods

  • regulatory, scientific and technical excellence with a problem-solving approach

  • compliance with all applicable EMA, FDA and ICH regulations

  • GMP, GLP, GCLP/GCP environment

Your one-stop shop for analytical services

Outsource your analytical needs on one site for more efficiency including:

  • Analytical development

  • Validation of analytical methods as per ICH guidelines

  • Characterisation

  • Stability studies

  • Batch testing

  • Bioanalytical services

GENERAL QUALITY
Appearance / pH / Osmolarity / Properties after reconstitution  
Particulate matter Optical microscopy / Light obscuration / Imaging Particle Analysis
Particle size (formulations) DLS
Water content / residual moisture (if lyophilised) (Coulometer) KF titration
IDENTITY
Intact oligonucleotide (U)HPLC (UV, RI, fluorescence, MS)
Molecular weight ESI-MS / MALDI-TOF
Nucleotide composition / Sequencing UPLC (UV, MSE) / MALDI-TOF
QUANTITY
Assay UV / (U)HPLC (UV, MS) / Solpe Spectroscopy (SoloVPE)
Absolute oligonucleotide content determination UV + ICP-MS
Determination of extinction coefficient UV + UPLC (UV) / ICP-MS
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, MALS)
Molecular backbone composition (P=S / P=O) ICP-MS
Chemical modifications and degradation patterns ESI-MS / (U)HPLC (UV, MS) / CGE (UV, LIF, MS) / IEX / RP-(U)HPLC (UV, MS) / SEC-MALS /
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 read outs
PROCESS-RELATED IMPURITIES
Microbiology Bioburden / Sterility (filtration, direct inoculation)
Endotoxins LAL (kinetic, end point), Monocyte Activation Test
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>
Download the product sheet for more information