Ark makes major advances in adenoviral gene-based medicine production

Ark Therapeutics" 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 specialist healthcare group with operations in London, UK and Finland said the new process has resulted in a very high quality finished product with improved yields of up to 100 times those achieved by conventional adherence cell or non-disposable bioreactor suspension cell culture and chromatographic purification processes.

In addition, the SUS system occupies 25% of the space previously needed for conventional production and, being disposable, results in considerable cost- and time-savings with reduced 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 GMP 3 facility was designed around SUS production and will be fully validated in early 2010 giving Ark significantly increased production capacity.

Robert Shaw, responsible for technical services at Ark, said: "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."

Ark has its origins in businesses established in the mid-1990s by Professor John Martin and Mr Stephen Barker of University College London and Professor Seppo Ylae-Herttuala of the AI Virtanen Institute at the University of Kuopio, all of whom play leading roles in the company's r&d programmes.