FDA Approves Biogen's Amevive Facility


Last month, the FDA approved Cambridge, Mass.-based Biogen, Inc's large-scale plant in Research Triangle Park, N.C., which will produce the chronic plaque psoriasis treatment, alefacept (Amevive), as well as other products now in developmental stages.

Described as one of the largest biopharmaceutical plants in the world, the facility includes 90,000 L of bioreactor capacity, in the form of six 15,000-L stirred tank ABEC bioreactors, the largest of their kind licensed.

The site uses microfiltration for clarification, three-step chromatography for capture and polishing purification, viralfiltration, and microfiltration for buffer exchange and concentration. Biogen used a modular design to build the facility. A separate purification suite, now in the validation stage, will allow it to manufacture two products at the same time.

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