Oxford BioMedica
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Manufacturing

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

The Group’s proprietary manufacturing 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 manufacturing 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 manufacturing 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.

Oxford BioMedica, supported by the consortium, will expand its proprietary manufacturing facility in Oxford to incorporate a third production suite and a state-of-the-art fill and finish operation; and develop its capability in serum-free, non-adherent manufacturing techniques. The project will bring significant benefits to our clinical programmes and further strengthens our position as a partner of choice for companies seeking manufacturing and process development solutions for gene-based ATMPs.

The manufacturing deal with Novartis announced in H2 2014 is a strong endorsement of our expertise and our ability to deliver on complex development and manufacturing 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 manufacturing for the lentiviral vector associated with the new programme.

Recent expansion of facilities
Batch manufacturing for Novartis continues to fully occupy Harrow House facility. Harrow House facility GMP2 expansion and upgraded enabling services are likely to complete in the first few months of 2016. The new Yarnton manufacturing facility received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products (IMPs). The MHRA conducted a site-specific inspection in November 2015 to evaluate whether the Group’s existing manufacturing processes and quality management systems had been effectively extended and implemented at the new Yarnton facility and remained in accordance with EU Good Manufacturing Practice (GMP) standards.

MHRA has now confirmed that Oxford BioMedica’s operations at Yarnton are in compliance with the principles and guidelines of GMP. Consequently, the facility at Yarnton is now fully-operational and authorised to perform GMP manufacturing activities. The successful delivery and licensing of the Yarnton facility provides the Group with a second fully independent GMP manufacturing site, strengthening the robustness of the Group’s biologics supply chain, adding dual sourcing capability and doubling capacity. 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.

Windrush Court facility laboratory construction well underway, completion expected in the first few months of 2016.

Facts

4,400ft2

The facility includes c. 4,400 square feet in cleanrooms


GMP Manufacturing

Click here to view our GMP Manufacturing brochure


Almost 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

Normal vision

Normal vision

A scene as it might be viewed by a person with normal vision.
Courtesy: National Eye Institute, National Institutes of Health (NEI/NIH) Ref#:EDS01


OXB Solutions

OXB Solutions

Our investment in building biomanufacturing capability in-house is enabling both us and our industry partners to advance valuable gene and cell therapy products to the market