13 February 2008 - Ark Therapeutics Group plc (“Ark” or the “Company”) announces today that it has completed the detailed review of facility validation and documentation upgrades to enable its Finnish gene therapy manufacturing facility to meet US as well as European Good Manufacturing Practice (GMP) standards.
Ark’s facility was approved in late 2005 by the Finnish National Agency for Medicines (NAM) on behalf of the European Medicines Evaluation Agency (EMEA) as the first ever facility to be allowed to manufacture adenoviral gene-based medicines for commercial supply in Europe. The facility passed its first routine NAM inspection in 2007 demonstrating Ark’s success in maintaining the production standards over time. This recent upgrade brings the facility’s engineering validations and documentation standards into line with the requirements needed for US commercial supply.
The project has taken seven months to complete and was overseen by the head of the international manufacturing and production consultancy Maijatech, a widely experienced GMP inspector who recently worked with the WHO inspectorate.
Robert Shaw, Technical Director at Ark, commented: “This has been a meticulous exercise scrutinising and evaluating our facility manufacturing documentation back to the late 1990’s and our recent facility compliance. To be able to show the history of continuous improvements to the production process as manufactured products move through their development life cycle is one of the critical elements in GMP and demonstrates the quality of Ark’s facilities and the competence of its staff in Finland.”
Dr Nigel Parker, CEO of Ark commented: “We are now confident that, subject to positive pre-approval inspections of an individual product’s dedicated production line, we can manufacture gene-based medicines for both EU and US commercial supply. This is a solid achievement for Ark.”
Enquiries
Ark Therapeutics plc Tel: +44 (0)20 7388 7722
Dr Nigel Parker, Chief Executive Officer
Martyn Williams, Chief Financial Officer
Financial Dynamics Tel: +44 (0)20 7831 3113 David Yates / Sue Quigley
