Oxford BioMedica
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Oxford BioMedica is a world leader in the development of lentiviral vector-based products. Our investment in building bioprocessing capability in-house is enabling both us and our industry partners to advance valuable gene and cell therapy products to the market.

Bioprocessing and the expansion of our facilities
The Group’s proprietary bioprocessing site, situated at Cowley, close to its headquarters in Oxford, UK, operates under GLP, GMP, GCP standards. In June 2012, Oxford BioMedica announced that it had received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products (IMPs) at its specialist bioprocessing facility. This represents an extension of Oxford BioMedica’s existing Good Manufacturing Practice (GMP) certification which covers the established in-house activities for testing and subsequent release of IMPs for clinical development.

Our bioprocessing facility is approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products (IMPs). This equips us with a broad range of capabilities for our in-house development projects which we also offer to partners and collaborators, including Novartis and Immune Design.

In order to cope with demand for our expertise and to be ready to take advantage of the maturing gene and cell therapy market in which the Company holds critical IP and expertise, Oxford BioMedica had to expand the facilities.

Throughout 2015 our existing Harrow House GMP1 clean room facility ran at full capacity and, to ensure availability for our in-house and partners’ programmes, we made good progress expanding our facilities. As a result, we have now established a second facility (GMP4) at Yarnton, Oxford and recently completed a second clean room (GMP2) in Harrow House, which is working towards MHRA licensure in 2016.

Our new Yarnton facility has now completed validation and been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for cGMP production, and this has now commenced. As a result, we now have dual sourcing, strengthening the robustness of our supply chain, and our cGMP clean room capacity has more than doubled to 950m2.

We are expanding this capacity further, and with the recent completion of GMP2 will have three independent production suites totalling 1,200m2. In addition, we have significantly expanded and upgraded our process development, analytics and quality laboratories at our wholly-owned Windrush Court facility, which is adjacent to our Harrow House bioprocessing facility, and we anticipate completing our relocation to these new laboratories in the next six months.

This significant growth in our capabilities is the result of approximately £19 million of investment between October 2014 and December 2015, which we anticipate will reach a final total of £26 million by the end of H1 2016. Oxford BioMedica now has the facilities to address further significant partnering demand for access to our process development and bioprocessing expert capabilities. The immune-oncology bioprocessing deal with Novartis announced in H2 2014 is a strong endorsement of our expertise and our ability to deliver on complex development and bioprocessing opportunities.

In January 2016, Novartis initiated work on a second CART programme for an undisclosed indication. Under an agreement signed with Novartis in the second half of 2014, Oxford BioMedica is undertaking process development and bioprocessing for the lentiviral vector associated with the new programme.

This additional capacity will support Oxford BioMedica’s own proprietary programmes in development as well as consolidating key current and potential new strategic relationships such as the well-established CAR-T focussed partnership with Novartis for CTL-019.

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The facilities are located at 2 independent sites with 3 separate cleanroom suites c. 1,200m2/12,917ft2

Over 10-years

We received GCP certification in 2006 from the MHRA and have continued to operate under GLP, GMP and GCP accreditations ever since, GMP certifications in 2005 and GLP accreditation in 2004. Our most recent MHRA GMP inspection of our facilities was in 2014