Additional cleanroom space took less than 12 months from concept to completion and creates extra capacity
UK cleanroom design and construction firm WH Partnership (WHP) has completed Oxford BioMedica’s new cleanroom production facility in Yarnton, Oxford, which manufactures gene-based medicines for some of the world’s largest pharmaceutical companies.
Constructed to comply with stringent UK Good Manufacturing Practice (GMP) regulations, the additional 560m2 of cleanroom space took less than a year from concept to completion and creates extra capacity.
WHP’s Managing Director, Nigel Hall, said: 'We have gained a strong reputation for our cleanroom design and construction in the biotechnology industry and the number and quality of projects that we have in the pipeline continue to grow. We are delighted to have brought our wealth of expertise in stringently-regulated sectors to OXB’s facility and look forward to supporting them in any future expansion plans.'
The Yarnton facility has also recently been approved by the Medicines Healthcare Products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products (IMPs).
We are delighted to have brought our wealth of expertise in stringently-regulated sectors to OXB’s facility
The additional capacity will support Oxford BioMedica’s proprietary programmes in development as well as consolidating key current and potential new relationships such as the well-established CAR-T focused partnership with Novartis for CTL-019.
Purposely designed around the Group’s current and future LentiVector based platform processes, the extra cleanroom space bolsters the Group’s manufacturing capabilities, and increases total operational capacity across its two sites to 950m2.
Further capacity expansion at the Group’s existing Harrow House facility (also based in Oxford) is scheduled for completion in the first half this year and will provide a third independent suite to house Oxford BioMedica’s next generation of serum free, suspension cell line based processes.
The firm says continued investment in its specialist biomanufacturing facilities and capabilities will help it address the industry’s challenges of bridging clinical and commercial supply, one of the main hurdles associated with the rapid progression of gene and cell therapies through Phase II and Phase III clinical trials, and then ultimately to market.
The successful commissioning of our second manufacturing facility is a landmark achievement for Oxford BioMedica
James Miskin, Chief Technical Officer of Oxford BioMedica, said: 'OXB is delighted with the recent completion of its new GMP cleanroom production facility in Yarnton. The WHP team worked closely and collaboratively with a small team of OXB in-house experts throughout the project, and WHP’s specific expertise, from detailed design to engineering solutions, was absolutely critical in completing this high quality facility in such a short period of time.'
John Dawson, Chief Executive of Oxford BioMedica, added: 'We are world leaders in the development of lentiviral vector-based products and the successful commissioning of our second manufacturing facility is a landmark achievement for Oxford BioMedica.
'This investment brings significant potential not only to support our own current and future pipeline of gene and cell therapy products in development but also to support our key collaboration with Novartis.
'Our IP, know-how, manufacturing operations and capacity now position Oxford BioMedica very strongly for securing further new partnerships and alliances.'