— MHRA approval received to enable GMP manufacturing for clinical supply —
Oxford, UK – 8 June 2012: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), the leading gene-based biopharmaceutical company, today announces that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products (IMPs) at the Company’s specialist manufacturing facility in Cowley, Oxford. 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.
The MHRA conducted an initial site inspection in March 2012, and a follow-up inspection in May 2012, to evaluate whether the Company’s processes, facilities and quality management systems were in accordance with EU GMP standards. The inspection had a successful outcome as the MHRA confirmed that Oxford BioMedica’s operations are in general compliance with the principles and guidelines of GMP as laid down in Commission Directive 2003/94/EEC. Having attained GMP certification, the manufacturing plant is now fully-operational and authorised to perform GMP manufacturing activities in support of clinical supply.
The investment in the Company’s specialist manufacturing processes will address one of the main hurdles associated with the rapid progression of products through Phase II, Phase III and to market. Importantly, it also provides the opportunity for Oxford BioMedica to become the LentiVector® platform supplier of choice for its current and future partners. The Company’s manufacturing and quality teams are complemented by the recently established Manufacturing Sciences and Technology (MSAT) team, whose operational and technical experience covers all aspects of manufacturing and brings together expertise in process development, process improvement and optimisation, technology transfer and process monitoring and troubleshooting. Oxford BioMedica therefore has the necessary capabilities and core competencies to develop and support current and future production activities.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: “We are world leaders in the development of lentiviral vector-based products and the successful commissioning of our proprietary manufacturing facility is a landmark achievement for Oxford BioMedica. This investment brings significant potential not only to support our current programmes and collaborations, but also to secure new partnerships and alliances.”