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Liverpool CMO Opens GMP Manufacturing Facility

PharmaManufacturing.com
05/21/2007

Eden Biodesign Ltd., a fast-growing biopharmaceutical development and manufacturing services company, announced May 21 that it has been awarded a licence by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to manufacture Investigational Medicinal Products (IMPs) at its new state-of-the art facility in Liverpool, UK.

The UK National Biomanufacturing Centre operated by Eden Biodesign came on-line for process and analytical development in May 2006. The MHRA inspection took place earlier this year to certify Eden’s processes and facilities as having reached the international Good Manufacturing Practices (cGMP) standard. The new license will provide legal authority for Eden to manufacture biopharmaceutical drug substances under contract for clients for use in EU clinical trial sites.

Dr. Crawford Brown, CEO of Eden Biodesign, commented: “Eden is now fully on track and able to deliver a full range of services for the production of mammalian, microbial and virus-based experimental medicines for a worldwide client base.”

He added, “We are particularly delighted as we designed the UK Biomanufacturing Centre that we operate and the MHRA license is recognition of our expertise in process development, cGMP manufacturing for clinical studies of new medicines and analytical development”.

Following the successful inspection, Eden recently announced that it will provide ImmBio, based in Cambridge, UK, with a range of development and manufacturing services to rapidly advance their leading influenza vaccine forward towards a Clinical Trial Application.

Eden has also started to supply cGMP clinical manufacturing services to Onyvax, a private UK biotech company, for its ovarian cancer vaccine and extended a project with Silence Therapeutics plc (formerly SR Pharma plc), delivering the listed UK biotech with a whole cell microbial immunotherapeutic for the treatment of asthma and as a therapeutic in cancer and tuberculosis. For further information, visit www.edenbiodesign.com.