Ark to contract manufacture gene-based medicines

Innovator companies are increasingly offering contract services or manufacturing to provide an additional source of revenue, make potentially important contacts in the industry and help develop in-house knowledge and expertise.

Ark has now taken this route and will launch itself as a contract manufacturing organisation (CMO) while continuing to develop its in-house pipeline. This consists largely of gene-based medicines and Ark believes the expertise and manufacturing capacity that it has developed in this field will be sought on a contract basis.

Currently Ark is producing commercial supply and clinical trial batches of its own products in its two current good manufacturing (cGMP) facilities in Kuopio, Finland and is expecting to have another site fully operational later this year.

The third facility, which is currently undergoing validation, will use advanced disposable single use systems (SUS) to produce research and commercial scale batches.

Using SUS technology Ark made a “major advance​” in the production of adenovirus-based gene medicine products, achieving considerably higher yields than had previously been possible.

Yield increased by 100 times and the product was of a very high quality, according to Ark, and this was achieved by using SUS technology consisting of a disposable wavebag and membrane-based purification processing technology.

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Once this validation process is complete and the third facility is fully operation Ark believes it will have the capacity and flexibility to manufacture its own medicines and be a CMO.

The company signed its first contract on July 1 and will now be producing vascular endothelial growth factor C in an adenoviral vector (Ad VEGF-C) for Oy Lx Therapies.

Contract revenues could go some way to overturning the £13.9m operating loss the company made in the first six months of 2009 and help support it until it receives marketing approval for one of its in-house products.