The good manufacturing practice (GMP-3) accredited plant is located near Ark's manufacturing and laboratory suites in Kuopio, Finland. The site will be used for the production of clinical grade gene-based medicines, including the firm's range of modified viral vector constructs.
The UK-headquartered drugmaker said that the new production capacity, in addition to its existing GMP-1 and GMP-2 facilities, means that it is now totally self sufficient for the manufacture of the gene medicines in its portfolio, including Cerepro (sitimagene ceradenovec) and Trinam (EG004).
Ark's CEO, Nigel Parker, said that: "with its own manufacturing facilities, Ark will not only have control over the production process but most importantly it will enable the company to retain the whole of the profit margin on what we believe will be highly valuable products."
These thoughts were echoed by Ark's technical director, Robert Shaw, who said that the new facility will enable the firm to take advantage of Finland's talented pool of scientists. He added that: "As regulatory standards increase, it is essential that Ark has the internal capability to manufacture at all levels so it can ensure quality standards are set, achieved and maintained throughout all phases of the product development cycle."
Industry analyst Robin Davison, head of healthcare research at Edison Investment Research, told in-PharmaTechnologist.com that completion of the manufacturing facility was a real achievement for Ark.
Davison explained that: "if upcoming data from trials of Cerepro, which are due to be released in the next few weeks, show that it confers a survival advantage over competitor treatments, Ark is likely to seek a partner to help it launch the product on the US market early next year."
He added that the additional manufacturing capacity provided by the new plant and the control that it affords over production "will enable Ark to leverage a significantly higher proportion of Cerepro's potential value."
Three-year project
Construction of the Kuopio facility, which was funded by Ark's €10m investment and a €2.2m grant from Finland's Employment and Economic Development Centre (EEDC), has taken just under three years. The project involved contributions from a wide range of industry specialists, although work on the basic manufacturing areas was completed by Novo Nordisk's Engineering Pharmaplan division.
The site features 547 square metres of clean room space and two serviced manufacturing suites each with separate vial filling, washing and depyrogenation areas. It also has a packaging area that is complete with vial decontamination, visual inspection units and labelling equipment.
In addition, the heating, ventilation and air conditioning system features a HEPA filtration unit to ensure that pure fresh air is supplied to the facilities bio-safety level 2 (BSL2) areas where the manufacture of viral based products will be performed. Furthermore, continuous monitoring of the non-viable particles and pressure differences will be carried out by a validated facility monitoring system.
