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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

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Accelerated development and commercialization

LentiVector™ platform and inAAVate™ platform processes with demonstrated consistency and scalability.

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Comprehensive assay portfolio

55+ validated methods, with the majority performed in-house for speed and control.

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Regulatory-ready documentation

CMC module support and Analytical Validation Master Files.

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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

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

Lentiviral-specific assays

  • Vector titre
  • Genomic titre
  • p24 ELISA
  • RCL
AAV

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

Product-specific assays

  • Potency
  • Transgene expression
  • Identity
Upcoming

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.

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Related resources

Enhancing Titres of Therapeutic Viral Vectors using the Transgene Repression in Vector Production TRiP System

17 September, 2024 | Lentivirus, Upstream Innovation

This paper describes using a TRiP system to temporarily repress transgene expression during production, boosting viral vector titers for therapeutic use.

View PDF >
Journal Papers

Frequently asked questions

What regions does OXB serve for viral vector analytics?
Do you support international clients remotely?
Are your facilities compliant with international regulations?
Can OXB support clinical and commercial supply globally?
What potency assays does OXB offer?
Can OXB develop custom assays for unique products?
How quickly can analytics results be delivered?
What expertise does OXB’s Analytics and QC teams bring to partners?