Viral Vector Characterisation and Release Testing
Products & Services
Information
Our experts have worked on multiple studies involving wild type and genetically modified (GMO) BSL-1 and BSL-2 viruses, including as Adenoviruses, adeno-associated virus (AAVs) and Lentivirus over the past 20 years. With a wide range of expertise and technology in-house, we deliver comprehensive advanced characterisation programs to support your product development, formulation, regulatory submission and production. This includes regulatory compliant (GLP/cGMP) assays for release testing, bioanalysis, characterization and stability. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
Viral Vector Purity
One major concern for vector purity is the determination of empty vs full capsids or capsids that contain DNA other than the desired full-length vector genomes. We can apply a range of the approaches including cryo-transmission electron microscopy (cryo-TEM), size exclusion chromatography (SEC) and analytical ultracentrifugation (AUC).
Vector Identity
Transgene expression (RTqPCR and ELISA)
Liquid chromatography and mass spectrometry (LC-MS) studies on whole virus species to characterise the viral proteome
Rapid screening of viral proteome fingerprinting by chromatography (HPLC), MALDI mass spectrometry and gel electrophoresis (SDS-PAGE). MALDI is useful for proteins up to around 150 KDa.
Digestion of isolated proteins followed by LCMS and/or MALDI-MS to give detailed information to assist the identification of viral proteins
Potency
One of the most critical lot release assays for an AAV vector is vector genome (vg) titer assay since genome copy numbers are universally used for dosing purposes in both preclinical and clinical studies. Our team overcome the limitations of quantitative PCR (qPCR) by applying digital droplet PCR (ddPCR) which does not use standards, and so improves reproducibility whilst offering greater sensitivity.
