Analytics

We perform a wide range of analytical assays within our in-house QC labs, with extensive qualification and validation experience to support clinical and commercial supply.

OXB has developed and optimised the analytics required for product commercialisation

Superior analytics allow us to understand both vector attributes and process performance throughout development and during routine quality control. The challenging analytical methods associated with complex products like lentiviral or AAV vector-based gene therapeutics requires specialist knowledge, techniques, and equipment. We offer an exceptionally comprehensive suite of in-house assays, ensuring full vector characterisation, quality control and stability testing, and preparing CMC modules 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. OXB is one of the very few companies in the world that can offer in-house, CGMP, RCL (Replication-competent lentiviruses) 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.

Platform assays

pH, Residual sodium butyrate, Endotoxin, Bioburden, Sterility, Mycoplasma, Micro BCA Total protein, _HCP ELISA, Endonuclease, Picogreen _Residual total DNA, _18S _Residual host cell DNA, _KanR _Residual plasmid DNA, _ABC-G _Residual plasmid DNA, _SV40 _Residual host cell DNA

Lentiviral specific assays

Vector titre, FACS, RNA copy number, p24 ELISA, RCL, RCLCC

Product specific assays

Potentcy, FAC’s

Upcoming platform assays

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

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)