UK regulators OK two Oxford Biomedica sites for cell therapy processing
The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the sites – a recently established clean room at its Harrow House facility in Cowley and a new laboratory at its headquarters in Oxford - last week.
Oxford Biomedica bought the Harrow House plant from RecipharmCobra Biologics – now Cobra Biologics – in 2011. The site houses single-use bioreactors for the production of medicines delivered using lentiviral vectors.
Activities at the Windrush court facility are focused product analysis for batch release and process development for Oxford Biomedica’s internal products and for those of its customers.
The approval means Oxford Biomedica now has three clean room facilities in the UK.
The third, at a site in nearby Yarnton, has been making lentiviral vectors for Novartis’ candidate lymphoma cell therapy - CTL-019 – since it was cleared by the MHRA in January.
According to Oxford Biomedica the Harrow House facility will support production of both CTL-019 and a second undisclosed chimeric antigen receptor T cell (CAR-T) programme on which it is collaborating with the Swiss pharmaceutical firm.
The facility will also make vector-delivered candidate therapies for other customers like Sanofi, Immune Design Corp. – the cancer therapy LV305 – and GSK, which has been working with the firm since December 2013.
Oxford Biomedica also confirmed it intends to vacate its office at the Medawar Centre at the neighbouring Oxford Science Park by the end of October.
