Viral Vectors

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

Building on our considerable experience in the analysis of complex innovative drugs, Quality Assistance is continuously advancing ways to support the development of your products. We continuously invest in new technologies and machinery and are able to assist you in the development of your recombinant AAV products from early phases to marketing authorisation.

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)