State-of-the-art manufacturing facility commences GMP production for a range of novel immunotherapeutics
Eden Biodesign announces full operation of its state-of-the-art GMP manufacturing facility
Eden Biodesign Ltd announced 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.
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, 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.
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