Customised single-use solution for production of gene-based products

Ark Therapeutics Oy needed a BSL-2 cell culture manufacturing plant based on single-use process technology and had a short timeline to realise it, so they turned to NNE for the solution.

Being a research and development company, Ark Therapeutics Oy had little experience with major engineering projects. So when it needed a facility established quickly using a single-use solution, Ark Therapeutics Oy looked for a partner with proven experience in single-use process technology and fast-track engineering.

Bringing experience to the table

With our expertise in single-use technology and award-winning fast-track solutions, NNE was a perfect fit. We were given complete responsibility for all site activities, including the design, installation, testing and qualification of cleanrooms, HVAC, media, clean utilities and process equipment for filling and primary packaging. NNE was able to provide a unique, tailored solution in just 16 months.

Unique facility for breakthrough products

The biological manufacturing operations provide process development and manufacturing capabilities for internal Ark Therapeutics programmes, as well as for third party clients for a variety of stages in therapeutic development. In the production facility, Ark Therapeutics is able to produce ground-breaking gene-based biopharmaceutical products based on modified viral particle technologies, as well as other biopharmaceuticals, up to biosafety level 2 (BSL-2).

Quick facts

Customer

Ark Therapeutics Oy

Country

Finland

Project duration

Feb. 2007 – Jun. 2008

Services provided

Basic design, detailed design, procurement support, installation management, commissioning supervision, qualification (up to operational qualification), validation support