Oxford Biomedica has developed and optimised analytics required for product commercialisation.

Superior analytical methods are essential to pharmaceutical product manufacturing, particularly throughout the development and quality control phases. The challenging analytical methods associated with complex products like novel lentiviral vector-based gene therapeutics requires specialist knowledge, techniques and equipment.

We offer an exceptionally comprehensive suite of in-house assays, ensuring full lentiviral vector characterisation, quality control and stability testing, and preparing CMC components for regulatory filings. We have an extensive clinical track record with our own and our partners’ products, and can advise our partners in the selection of appropriate assays. We also develop custom-made assays for specific applications or types of product. Oxford Biomedica is one of the very few companies in the world that can offer in-house, GMP, RCL (Replication-competent Leniviruses) testing from purpose-built category 3 labs.

Our manufacturing sites are registered with the FDA and we hold manufacturing authorisations for clinical trial products and commercial products.

Key analytic methods

Platform assays:

  • pH
  • Residual sodium butyrate
  • Endotoxin
  • Bioburden
  • Sterility
  • Mycoplasma
  • Micro BCA
    Total protein
  • Endonuclease
  • Picogreen
    Residual total DNA
  • 18S
    Residual host cell DNA
  • KanR
    Residual plasmid DNA
  • VSV-G
    Residual plasmid DNA
    Residual host cell DNA

Lentiviral specific assays:

  • Vector titre
  • FACS
  • RNA copy number
  • p24 ELISA
  • RCL

Product specific assays:

  • Potency
  • FACS

Product specific assays:

  • Mass spectrometry
  • Next-Generation Sequencing
  • HPLC based vector quantification