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:
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customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development
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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
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regulatory, scientific and technical excellence with a problem-solving approach
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compliance with all applicable EMA, FDA and ICH regulations
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GMP, GLP, GCLP/GCP environment
Your one-stop shop for analytical services
Outsource your analytical needs on one site for more efficiency including:
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Analytical development
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Validation of analytical methods as per ICH guidelines
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Characterisation studies
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Bioassays
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Bioanalytical services
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Stability studies
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Batch testing
GENERAL PROPERTIES
| Appearance | |
| 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 |
MANUFACTURING RESIDUALS
| 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) |
PACKAGING
| 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> |
POTENCY
| Cell based assay | Different readouts |
IDENTITY
| Genome sequencing | NGS |
| Genome identity | PCR / restriction enzyme mapping |
| Viral vector | (U)HPLC (MS) / Immunoassays (ELISA, Gyrolab, BLI, SPR,...) / SDS-PAGE |
PURITY & INTEGRITY
| 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 |
QUANTITY
| 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 |
EXCIPIENTS
| Assay / impurities | GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS) |
