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Comprehensive viral vector analytics for cell and gene therapy
At OXB, quality and regulatory excellence are central to everything we do. With decades of experience advancing viral vector therapies, we’ve helped bring products to patients worldwide by embedding quality and regulatory foresight into every stage of development and manufacturing. From IND through commercial launch, our team partners with you to anticipate challenges, de-risk programs, and ensure successful engagement with global health authorities.
Why OXB for analytical testing?
Industry-leading analytical services for viral vector-based gene therapies
Accelerated development and commercialization
LentiVector™ platform and inAAVate™ platform processes with demonstrated consistency and scalability.
Comprehensive assay portfolio
55+ validated methods, with the majority performed in-house for speed and control.
Regulatory-ready documentation
CMC module support and Analytical Validation Master Files.
Global footprint
Facilities and support across the EU and US, providing worldwide reach for your viral vector programs.
Our product assays
Explore our comprehensive suite of viral vector assays. We also develop bespoke assays for unique products, including in-house CGMP RCL testing from BSL-3 facilities.
Platform assays
- pH
- Osmolality
- Appearance
- Residual sodium butyrate
- Endotoxin
- Bioburden
- Sterility
- Mycoplasma
- Micro BCA total protein
- HCP ELISA
- Endonuclease
- Total residual DNA (Piocgreen)
- 18S residual host cell DNA
- Residual plasmid DNA
- SV40 residual host cell DNA
- E1A residual host cell DNA
Lentiviral-specific assays
- Vector titre
- Genomic titre
- p24 ELISA
- RCL
AAV-specific assays
- Transgene expression
- TCID50 for infectivity
- In vitro potency
- Capsid titer by ELISA/GyroLab
- Size Exclusion Chromatography (SEC) for aggregates
- Analytical Ultracentrifugation (AUC) and CD-MS for empty/full/intermediate capsids
- CE-SDS for capsid purity
- Residual affinity ligand by ELISA and mass spec
- Capsid identity by mass spec
- Vector and plasmid characterization by NGS (PacBio)
Product-specific assays
- Potency
- Transgene expression
- Identity
Upcoming platform assays
- Mass spectrometry
- HPLC-based vector quantification
Contact an analytics expert
Share your program details and timelines and we’ll recommend the best assay strategy and support your regulatory pathway.
Explore OXB’s other CDMO solutions
Related resources
The TetraVecta™ System: Optimisation & Exemplification of OXB’s Next Generation Lentiviral Vector
View PDF >Enhancing Titres of Therapeutic Viral Vectors using the Transgene Repression in Vector Production TRiP System
This paper describes using a TRiP system to temporarily repress transgene expression during production, boosting viral vector titers for therapeutic use.
View PDF >