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Comprehensive viral vector analytics for cell and gene therapy
OXB provides industry-leading analytical services for viral vector-based gene therapies, including lentiviral and AAV platforms. Our in-house CGMP QC labs, purpose-built BSL-3 facilities, and global regulatory expertise enable full vector characterization, potency assessment, stability testing, and custom assay development, supporting clinical and commercial supply worldwide.
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 >Frequently asked questions
OXB supports programs across the EU, US, and worldwide, offering a global footprint for viral vector programs supporting both cell and gene therapies.
Yes. We provide remote analytics strategy support, CMC documentation, and regulatory guidance to clients worldwide.
Absolutely. Our labs are CGMP-compliant, FDA-registered, and equipped with BSL-3 RCL testing capabilities, ensuring regulatory-ready analytics for clinical and commercial programs.
Yes. Our global presence and standardized protocols enable us to deliver analytics and quality control support for both clinical trials and commercial supply across multiple regions.
OXB provides a broad suite of potency assays, including transduction efficiency, p24, enzymatic activity, and functional readouts, that demonstrate product quality, consistency, and mechanism of action. These assays are validated and have been accepted by global health authorities, supporting both clinical and commercial submissions.
Yes. We design and validate bespoke assays tailored to unique viral vector products, including in-house CGMP RCL testing from BSL-3 facilities and product-specific potency assays.
Turnaround times vary depending on the assay and program, but our high-throughput automation and validated in-house methods enable faster GMP batch release and regulatory submissions.
OXB’s QC scientists and analysts are highly trained in advanced assay development, validation, and lifecycle management. Their expertise ensures robust analytical packages that meet global standards, with a strong focus on method robustness, accuracy, and compliance.