Det var ett glädjande besked om att ICON nu kontrakteras för att hjälpa till med förberedelserna för kommande fas-III studie.
Start av studie samt start av GAD produktion i Umeåanläggningen kommer ske senare under detta år.
Angående installation och tids- och produktionskapacitet av FlexFactory i Umeåanläggningen kan vi läsa följande på Cytivas hemsida 
Q. I already have a facility. Can I install a FlexFactory platform, and how long will it take?
A. Yes. The FlexFactory platform is designed to fit a new or an existing manufacturing plant and can be set up for production at a site of your choice. A FlexFactory installation will be fully qualified and ready to run 6 to 9 months after completing conceptual design. Conceptual design can take 2 to 3 months, so the overall project timeline is between 9 and 12 months.
Q How much space is needed to be able to install FlexFactory?
A. The footprint of the production platform depends on the chosen configuration and your production capacity needs. The FlexFactory platform can be configured for production bioreactor scales of 200, 500, 1000, or 2000 L. A 2000 L FlexFactory setup needs a processing/manufacturing area footprint of around 400 m2 while a 500 L setup requires slightly less room.
Q. Which biologics can I manufacture?
A. Biologics such as mAbs or vaccines can be manufactured on a FlexFactory platform.
Q. What is the process scope of FlexFactory?
A. A FlexFactory platform gives you the necessary process equipment from cell culture expansion systems through your seed and production bioreactors to bulk drug substance formulation. Cell culture harvest clarification is performed with a harvest pump and harvest filter holder. ÄKTA chromatography systems can be incorporated for protein purification. Viral filtration is performed using a viral filtration pump and viral filtration filter holder, and then on to a final concentration TFF/UFDF system. Lastly, a solution for fill and storage of bulk drug substance is provided.
Q. What is the production capacity?
A. Capacity is scalable from pilot production to commercial-scale production with FlexFactory. You can run up to 4 × 2000 L bioreactors with a single downstream processing train. In a mAb process, product titers are typically 2 to 4 g/L, and a 2000 L bioreactor with a process yield of 70% can be expected to have an output capacity of over 100 kg of product per year