Oxford Biomedica has brought GMP manufacturing capability at its Durham, North Carolina, facility online and completed the site’s first regulated manufacturing run, closing a six-month delay in the integration programme and adding commercial-scale US viral vector capacity to its global network.
The cell and gene therapy contract development and manufacturing organisation acquired the FDA-approved Durham operation in October 2025. Oxford Biomedica, which now uses OXB as its commercial brand, expects client activity at the facility to increase during the second half of 2026 following completion of the remedial work associated with the delay.
Durham is intended to strengthen OXB’s manufacturing position in adeno-associated virus, or AAV, alongside its wider multi-vector capabilities. The company has already assigned client programmes to the site, including an agreement announced in July with Plowshare Therapies covering process development and AAV GMP manufacturing for a rare-disease gene therapy programme.
Bringing a regulated biologics facility online involves considerably more than making production equipment mechanically available. Manufacturing suites, utilities, environmental controls, analytical methods, material flows, documentation, and operator procedures all have to function within a validated quality system.
Completion of the first GMP run is therefore an operating milestone because it tests the manufacturing process under controls required for material intended for regulated clinical or commercial use. Reaching that point also allows the facility to begin absorbing client work rather than remaining an integration asset.
The additional capacity arrives as OXB’s programme base continues to expand. In its interim results for the six months to 30 June, the company reported 17 new client wins, more than 30% above the number signed during the whole of 2025. Four more clients were added after the period end, taking the portfolio to 59 programmes across 50 clients.
Reported first-half revenue increased 9% to £79.8 million, while constant-currency revenue rose 10% to £80.2 million. Manufacturing services contributed £43.1 million, up from £36.0 million a year earlier, making production activity the largest component of group revenue.
OXB ended June with a revenue backlog of about £193 million and said approximately £168 million of forecast 2026 revenue was covered by contracted orders as of September. Those figures increase the importance of having manufacturing capacity available when client programmes reach the GMP stage.
Cell and gene therapy projects can spend years in development before moving into later clinical phases, but manufacturing schedules become more demanding once GMP material is required. Suppliers have to reserve suites, manage specialist raw materials, schedule analytical testing, maintain trained personnel, and coordinate release activity around relatively complex production campaigns.
Capacity that exists on paper but has not completed qualification cannot absorb that work. The Durham delay had already affected OXB’s 2026 planning, with the company reducing near-term revenue guidance in August partly because of later-than-expected operational readiness at the site and changes in client ordering behaviour.
OXB now expects constant-currency revenue of £180 million to £200 million for 2026 and a mid-single-digit EBITDA margin excluding one-off costs, while retaining its expectation for 25% to 30% revenue growth in 2027. Converting the Durham plant from integration project to operating facility removes one of the constraints behind that earlier adjustment.
The wider pharmaceutical manufacturing market is also placing greater emphasis on facilities capable of supporting programmes through several development stages without repeated transfers between suppliers. Investment in integrated bioprocessing capability and skills reflects the same pressure to reduce the gap between process development, scale-up, and regulated production.
Viral vectors add specific process constraints because yield, potency, purity, and analytical characterisation have to remain controlled as production moves into larger manufacturing environments. AAV processes combine upstream cell culture and vector production with downstream purification and an extensive analytical package.
Scale changes can affect fluid dynamics, hold times, purification performance, and process consistency. Commercial-scale equipment can increase throughput, but the manufacturing process still has to reproduce critical parameters closely enough to meet client and regulatory specifications campaign after campaign.
OXB’s network now spans the UK, France, and the US, allowing programmes to be allocated according to vector type, development stage, and available capacity. That geographical spread reduces dependence on a single site but increases the importance of common quality systems and disciplined technology transfer.
A process transferred between facilities has to reproduce its critical parameters and analytical results closely enough to avoid introducing variability that could require additional development or regulatory work. Durham therefore adds useful capacity only if its processes perform consistently within the wider OXB network.
OXB is targeting approximately £500 million of revenue by 2030, with long-term EBITDA margins approaching 30% as utilisation and operating leverage improve. Those ambitions depend on signed programmes moving into repeatable manufacturing work across the group’s facilities.
The first GMP run does not remove execution risk after a six-month delay, but it changes Durham’s role materially. The facility can now begin serving clients under regulated manufacturing conditions, and the next measure will be how quickly scheduled programmes fill that capacity and contribute to the utilisation required for OXB’s 2027 growth plans.
