Eden Biodesign Begins GMP Bio-Production

Eden Biodesign Ltd. has been licensed by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to manufacture Investigational Medicinal Products (IMPs) at its new facility in Liverpool, UK. The UK National Biomanufacturing Centre 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 cGMP standards. 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, Eden Biodesign’s chief executive officer, 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.”

Following the successful inspection, the company will provide Cambridge, UK-based ImmBio with a range of development and manufacturing services to rapidly advance its influenza vaccine towards a Clinical Trial Application. Eden has also started to supply cGMP clinical manufacturing services to Onyvax, a private UK Biotech, for its ovarian cancer vaccine, and extended a project with Silence Therapeutics plc (formerly SR Pharma) to deliver a whole cell microbial immunotherapeutic for the treatment of asthma and as a therapeutic in cancer and tuberculosis.