Ark Therapeutics receives approval for new production site

Ark Therapeutics' newest and largest production facility GMP 3 has received an approval from the Finnish Medicines Agency (FIMEA).

Following a recent inspection, the FIMEA has extended Ark's Good Manufacturing Practice certification to include the site, thus greatly increasing the company's global manufacturing capacity.

The facility includes an automated fill-and-finish line capable of handling up to 2,000 product units per hour and is designed for larger-scale production from suspension cell cultures, utilising cutting-edge single-use systems.

Coinciding with this, the firm also recently appointed Dr David Venables to its board as executive director of manufacturing services.

Martyn Williams, chief executive officer of Ark Therapeutics, said these initiatives "are key steps forward in the next phase of Ark's development, providing us with a facility which will directly benefit both Ark's own programmes and those of an increasing number of our third-party clients".

This comes after the company achieved the first milestone in a colorectal cancer drug manufacturing alliance with PsiOxus Therapeutics earlier this year.