GMP certification positions Eden for clinical trial supply
services company that runs the UK's National Biomanufacturing
Centre (NBC), has now been cleared to produce investigational
medicinal products for clinical trials at its facility in Speke,
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) inspected the facility earlier this year to certify its compliance with international current Good Manufacturing Practice (cGMP) standards. The MHRA licence provides legal authority for Eden to produce biopharmaceuticals under contract for clients to use at clinical trial sites in the European Union, the company noted. "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," said chief executive officer Dr Crawford Brown. In line with its cGMP status, Eden recently announced that it would provide UK biotech ImmBio with a range of development and manufacturing services aimed at moving the Cambridge-based company's lead influenza vaccine swiftly towards a Clinical Trial Application. Eden has also started to supply cGMP clinical manufacturing services to UK biotech Onyvax for the latter's cell vaccine programme against ovarian cancer. The Onyvax-O vaccine, which is being developed by Onyvax under a collaborative licence agreement with the US Mayo Clinic, is currently in preclinical trials. The ovarian carcinoma cell lines were developed by the Mayo Clinic for use as human therapeutics. The Onyvax contract was the first at the NBC to benefit from the £2.7m (€3.95m) Access Fund, supported by the UK Department of Trade and Industry and the European Regional Development Fund, that helps qualifying small-to medium-sized companies and academic groups to purchase development and clinical manufacturing services from the Centre. In addition, Eden has extended a project with Silence Therapeutics (formerly SR Pharma) that involves delivering to the UK biotech a whole-cell microbial immunotherapeutic for the treatment of asthma, cancer and tuberculosis. Eden originally agreed in December to supply SR Pharma with a 12-month package of strategic product development consultancy and biomanufacturing services related to one of the latter's innovative product technology platforms. Eden noted at the time that SR Pharma's proprietary technology based on Mycobacterium vaccae, a species of bacteria with the potential to trigger T-cells in the body that 'switch off' inappropriate Th2 lymphocyte activity, had been "the source of a number of product developments which have been evaluated for the treatment of asthma and as a therapeutic in cancer and tuberculosis". While M. vaccae was the original technology on which SR Pharma was founded, it is no longer considered core to the group's strategy, which revolves around novel siRNA, or more specifically AtuRNAi, molecules delivered using the company's proprietary systemic delivery system, AtuPLEX. Nonetheless, Silence Therapeutics continues to evaluate the development possibilities of the M. vaccae technology in collaboration with third parties. The name change to Silence Therapeutics last month reflected the company's increasing focus on its RNAi technology, which involves 'silencing' disease-relevant genes. Between 2001 and 2006, Eden Biodesign provided biopharmaceutical development services to more than 70 clients in Europe, US, Asia and Australasia, ranging from large pharmaceutical companies to major charity organisations. Formally opened in November 2006, the £34.25m National Biomanufacturing Centre is a government-funded initiative to help biotechnology start-ups get their product ideas into clinical trials. The facility came onstream for process and analytical development in May 2006.