Oligonucleotides

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.

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
  • Bioanalysis
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)
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>
Download the product sheet for more information