London, UK, 24 June 2009 - Ark Therapeutics Group plc (‘Ark’ or the ‘Company’) announces today that it has made a major advance in its production technology and processes for commercial manufacture of adenoviral gene-based medicines. Ark’s production development group in Kuopio, Finland, has developed a suspension process based on single use systems (SUS) for manufacturing commercial sized batches of adenoviral gene-based medicines ready for fill.
SUS is based on disposable wavebag and membrane-based purification processing technology, and allows use of the reversing flow system invented by Ark. The new process has resulted in a very high quality finished product with improved yields of up to 100 times those achieved by more conventional adherence cell or non-disposable bioreactor suspension cell culture and chromatographic purification processes.
The SUS system occupies a quarter of the space previously needed for conventional production and, being disposable, results in considerable cost and time savings with reduced facility and equipment sterilisation ‘down time’. The extensive use of contained process elements opens up hitherto product-specific production theatres for potential manufacture of more than one product line.
The Company’s new facility (GMP 3), was designed around SUS production and is expected to be fully validated in early 2010 giving Ark significantly enhanced production capacity.
Robert Shaw, Operating Board member responsible for technical services at Ark, commented: “These material improvements to our manufacturing capabilities enable us to move from a continuously running commercial supply process, which was both labour and facility intensive, to a system where we can see yields of 5,000-20,000 doses in a single short run. This is a major step forward for us and the gene-based medicine sector.”
Dr Nigel Parker, CEO of Ark, added: “The SUS system will have a significant impact on production and ultimately cost of goods and we have strong intellectual property to protect our competitive advantage. We believe this process will work with all adenoviral gene-based products and is adaptable to other types of virus for gene medicine production.”
