Ark opens new manufacturing facility in Finland

The facility, built as a result of a co-operative agreement between the company and the University business park, is linked to Ark's existing manufacturing and laboratory suites and has been specifically designed for the manufacture of gene-based medicines, particularly those in viral vector constructs.

Operating to Biosafety Level Two (BSL2) and containing 547m2 of cleanrooms, it has taken three years to build and has been completed on schedule and on budget. Engineering fit-out of the basic manufacturing environment was carried out by Novo Nordisk Engineering Pharmaplan, of Denmark (NNE). The facility will be used initially for laboratory and pre-clinical grade production while equipping and validating dedicated production theatres to enable full GMP certification continues.

The products made in this facility will be based on modified live viral particle technologies. The manufacturing process will cover the whole production process, from biological bulk manufacture, through purification to filling and packaging of finished sterile product.

The layout includes two serviced manufacturing suites, and a separate filling area with full vial washing, depyrogenation and filling equipment for filling of the product. The packaging area includes vial decontamination equipment, visual inspection, labelling and packaging for the vials. Clean service areas for washing and sterilising are located by the production areas.

Each of the BSL2 rooms is equipped for decontamination with hydrogen peroxide vapour.

The HVAC system has been designed to provide 100% fresh air to BSL2 areas. Both incoming and outgoing air in the whole facility is HEPA filtered. Pressure zones in the facility are designed to let the air flow from clean to less clean areas. Continuous monitoring of the non-viable particles and pressure differences is performed by the validated facility monitoring system.

Other utilities needed for the process, such as plant steam, clean steam, compressed air, water for injection and the waste inactivation system for liquid waste are located in the basement. Solid waste from the BSL2 area can be inactivated in the waste autoclave and the liquid waste will be drained to the waste inactivation system in the basement.

The design allows for the later addition of a second production suite on the first floor with no disruption to on-going production.

This facility complements the capabilities of Ark's existing production units (GMP 1 and GMP 2) and will allow the company to be fully self-sufficient for manufacture of all the gene-based products in its portfolio, including Cerepro for glioblastoma and Trinam for haemodialysis graft access surgery, for research, clinical trial and commercial supply.

Ark has invested €10m in the highly specialised gene-based manufacturing suites of this facility has been assisted by €2.19m of grant support from The Employment and Economic Development Centre of Finland (TE-Centre). This is the largest investment grant awarded to the biotech-pharma industry by the TE-Centre since its foundation in 2000.

‘This is a very high grade facility which is complementary to Ark's existing manufacturing capabilities in Kuopio and enables the company to take advantage of the quality science and technology in Finland,’ said Robert Shaw, technical director at Ark.