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Abbott Laboratories has opened a new biologics plant in Barceloneta, P.R., that will serve as the primary production site for Humira, a monoclonal antibody for the treatment of arthritis and Crohn's disease. Carrying a $450 million price tag, the plant represents Abbott's largest capital investment to date. The site will also support the commercialization of other products in the company's pipeline. Meanwhile, Wyeth says FDA has completed a reinspection of its manufacturing site in Guayama, P.R., related to a May 2006 warning letter that raised concerns over the facility. The company plans to respond shortly to remaining concerns cited by the agency in the hopes that FDA will give it the nod to start production there. Final approval for Pristiq, Wyeth's drug for manic depressive disorder, hinges on a successful FDA inspection of the Guayama facility.
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