Does this plant get built with DENOSOMAB'S approval?
CORK, IRELAND (Oct. 3, 2007) Amgen today announced that following an updated review of its business plans, concurrent with an evolving business environment, the company has decided to postpone indefinitely its planned design and build-out of a bulk manufacturing facility in County Cork. Amgen expects to maintain ownership of the site property in cooperation with Irish authorities.
If not, where would it be produced?
A drug that big will surely need it's own multi-billion $$ plant built.
If you had a smidgen of brain cells you would stop presenting old, obsolete, irrelevant news and spam on these boards (Amgen and others) and do some homework. If you simply looked Amgen's annual report you would see the following.
Key manufacturing projects include: (i) construction, qualification and licensure of a new formulation and filling facility at our Puerto Rico site and (ii) expansion and the related qualification and licensure of our existing bulk protein facilities at our Puerto Rico site for the production of our late-stage product candidate, denosumab.
In Boulder, Colo., for example, Amgen transformed a plant designed to produce the drug Kineret into a so-called multi-product launch facility. The plant now produces Denosumab, an experimental drug for treating bone loss; Kepivance, a medicine for oral mucositis; and AMG 53, an experimental medication for stimulating the production of platelets.
That was producing enough for trials.
Not full scale ,"blockbuster multi-$billion drug" needs.
Interesting question...surprised that manufacturing site has not been decided. Figured Amgen would be in final production stages when they sent in application to the FDA. FDA has to do Preapproval Audit to get approval...so it is being made somewhere, but where???