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:
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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) |
