Viral Vectors

Due to their complex structure and size, as well as a constantly evolving regulatory landscape, the physico-chemical and biological characterisation of viral vector-based products is challenging.

With extensive experience in the analysis of innovative products and thanks to a continuous investment in new technologies and machinery, Quality Assistance can assist you in the development of your recombinant Adeno-Associated Viral Vectors (rAAVs) products from early phases to commercialisation.

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, Cell Biology, 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 studies

  • Bioassays

  • Bioanalytical services

  • Stability studies

  • Batch testing

pH / Osmolarity (if liquid)  
Water content / residual moisture (if lyophilised) KF titration (volumetric, coulometric, oven)
Particulate matter Optical microscopy / Light obscuration / Imaging Particle Analysis
Microbiology Bioburden / Sterility (filtration, direct inoculation)
Bacterial endotoxins and Pyrogens LAL / MAT / rFC
Extractable volume  
Residual solvents HS-GC (FID, MS)
Elemental impurities ICP (OES, MS)
Residual salts HPAEC (conductimetry) / ICP (OES, MS)
Residual HCP Immunoassays (ELISA, Gyrolab, BLI, SPR,...) / UPLC (MS-MS) / 2D-Gel / 2D-DIGE
Residual DNA qPCR / ddPCR / PicoGreen / Electrophoresis (agarose)
Residual RNA RiboGreen / Electrophoresis (agarose)
Residual benzonase Immunoassays (ELISA, Gyrolab, BLI, SPR,...)
Process contaminants (CsCl, iodixanol, antifoam, Triton X100, Tween, PEI,...) GC (FID, MS) / ICP (MS) / (U)HPLC (UV, CAD, MS, ELSD)
Leachables GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS)
Container Closure System Integrity Bubbling / Dye ingress / Microbial ingress
Cytotoxicity / Biological reactivity Cell-based assays / USP <87>
Cell based assay Different readouts
Genome sequencing NGS
Genome identity PCR / restriction enzyme mapping
Viral vector (U)HPLC (MS) / Immunoassays (ELISA, Gyrolab, BLI, SPR,...) / SDS-PAGE
Viral vector aggregates SEC-(U)HPLC(UV, RI, MALS) / A4F(UV, RI, MALS) / DLS / Imaging Particle Analysis
Replication competent viral vectors Infectivity assay (qPCR)
Full / Empty capsids CGE / Anion Exchange Chromatography (UV) / SEC-(U)HPLC (UV, RI, MALS) / SoloVPE
Genome integrity NGS, CGE, (U)HPLC/UV, ddPCR, qPCR
Protein degradation products / modifications (U)HPLC-MS
Infectious vector titer qPCR / ddPCR
Vector particle concentration qPCR / ddPCR / AEX / UV spectroscopy
Total protein BCA / Lowry / Bradford / UV / (U)HPLC (UV)
Capsid concentration Immunoassays (ELISA, Gyrolab, BLI, SPR,...) / MA-DLS
Assay / impurities GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS)
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