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Customised disposable solution for production of gene-based products


Ark Therapeutics Oy needed a BSL2 cell-culture manufacturing plant based on disposable process technology and they had a short time-line to realise it, so they turned to NNE Pharmaplan for the solution.

Ark Therapeutics Oy is a specialist healthcare group focused on areas of high unmet need in vascular disease, wound care and cancer. A research and development company, the organisation had little experience with major engineering projects. 

So when it needed a facility established quickly using a disposable solution, Ark Therapeutics Oy looked for a partner with proven experience in disposable process technology and fast-track engineering. The company also wanted the reassurance of a partner with a local presence in Finland. 


 
Bringing experience to the table
With its expertise in disposable technology and award-winning fast-track solutions, NNE Pharmaplan was a perfect fit and was able to provide Ark Therapeutics Oy with a unique, tailored solution – to be completed in just 16 months.

NNE Pharmaplan was 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.

Unique facility for breakthrough products
With site activities well under way, Ark Therapeutics Oy is especially impressed with NNE Pharmaplan’s efficient project management and attention to the unique safety requirements of the project.

In its new production facility, Ark Therapeutics Oy will now be able to produce what it hopes will be two of the first gene-based biopharmaceutical products based on modified viral particle technologies to be approved for the European market.

 

 

Got questions?

Anders Ernblad
Engineering Manager


Tel+46 8 59 49 60 00

facts


Client
Ark Therapeutics Oy, Finland
Client's success factors
Unique disposable solution, qualified BSL 2 facility up and running on a very tight time schedule
Project duration
Feb. 2007 – Jun. 2008
Service provided
Basic design
Detail design
Procurement support
Installation management
Commissioning supervision
Qualification (up to operational qualification)
Validation support


NNE Pharmaplan 2008
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