Driving advances ingene therapies

Oxford BioMedica: AMSCI and API Projects

Cowley/Yarnton, Oxford, UK

Oxford BioMedica (OXB), a spin-out of the University of Oxford, is a leading gene therapy manufacturer which has undergone rapid growth, and which had facilities that were dated and working at full-capacity.

AChris Abell and Bruce Nepp, the team formerly operating as Abell Nepp (AN) who are now part of Buro Happold, provided design services for two new state-of-the-art facilities: the AMSCI and API projects.

Oxford BioMedica (OXB) has undergone rapid growth in recent years, but needed new and improved facilities to allow for further development.

Chris Abell and Bruce Nepp, the team formerly operating as Abell Nepp (AN) who are now part of Buro Happold, provided design services for two new state-of-the-art facilities: the AMSCI and API projects.

Construction was carried out while other parts of the facility remained in use for manufacture.

This involved frequent coordination between the project team and the contractor to prevent contamination and disruption.

Challenge

The AMSCI project was supported by Finance Birmingham’s AMSCI (Advanced Manufacturing Supply Chain Initiative) programme which provided a grant for the project. The API Facility is an off-site gene and cell therapy manufacturing facility in an industrial unit.

Our experts prepared a masterplan for the phased fit-out and extension of OXB’s existing manufacturing facility to meet new objectives and planned future growth.

The master plan included the provision of new manufacturing suites, meeting and training space, open-plan write-up and welfare areas. The sinusoidal-profile-clad extension provides space for a new Fill and Finish facility, and the facade treatment was extended to the existing buildings for continuity.

It was critical that the projects were carefully managed, in order to allow OXB to continue manufacturing during the construction phase.

Our experts prepared a masterplan for the phased fit-out and extension of OXB’s existing manufacturing facility to meet new objectives and planned future growth. Image: Oxford BioMedica (OXB) | Abell Nepp.

Solution

The first phase (completed in March 2016), created a suite of GMP ISO 5, Class 100 clean rooms, and completed enabling works for the future phases. AN provided full laboratory architectural design, lead consultant, and contract administration services. Construction was carried out while other parts of the facility were in use for manufacture, meaning there was frequent coordination between the project team and the contractor to prevent contamination and disruption to OXB’s business operations.

The clean rooms were designed to be as flexible as possible to accommodate different types of manufacturing technique foreseen by OXB, meaning equipment, safety cabinets, and furniture is almost all mobile. Each clean room is designed with an apparent overprovision of services: to enable OXB to switch manufacturing processes quickly without further disrupting its business. As this is a manufacturing facility, the clean rooms are designed to withstand a chemically rigorous cleaning regime.

Through a mock-up approval process, Abell Nepp worked closely with OXB and the contractor to agree the precise details of the clean room’s wall, floor, and ceiling lining prior to their construction. The mock-ups and stringent cleaning tests resulted in a high-quality, practical and durable finish to the clean rooms.

The briefing stage involved consultation with OXB’s process specialist, and it was important to establish a series of sign off milestones to ensure that the project had been reviewed by the multitude of stakeholders involved.

To maintain the biological containment seal within the clean rooms, all services fittings are sealed and access for maintenance is from the void above the ceiling. HEPA filters are changed from above, which reduces disruption and the costly ‘deep cleans’ required by ISO 5 facilities. All the internal finishes and building insulations were specified to have an Ozone Depleting Potential of zero, and a low VOC (volatile organic compound) content. All lighting was specified as low-energy LED.

Value

Abell Nepp were architect and lead consultant for the two projects. The team brought a wealth of experience in planning and designing bespoke specialist laboratory facilities.