ImClone Systems has received approval from the FDA to manufacture multiple products at its BB50 manufacturing facility. This approval significantly expands ImClone’s total available production volume capacity for its proprietary pipeline of novel antibodies, which are now entering late-stage clinical development.

“This multi-product FDA approval of BB50 significantly enhances ImClone’s operational flexibility as we scale up production of our robust pipeline of proprietary antibodies for the growing number of Phase II and III trials that will be commencing in the next year,” said Richard P. Crowley, senior vice president, Biopharmaceutical Operations of ImClone. “ImClone has one of the largest biologic production capacities in the world and this approval is an important milestone in our efforts to maximize the global potential of both Erbitux and our portfolio of novel fully-human antibodies, which together represents one of the deepest pipelines in oncology today.”

ImClone’s 250,000-sq.-ft. multi-suite BB50 facility received FDA approval to manufacture Erbitux in August 2007. Together with the company’s BB36 manufacturing facility, ImClone has a total production volume capacity of up to 140,000 L at its Branchburg, NJ campus. This is among the largest antibody manufacturing capacities in the biotechnology industry and is a key component of ImClone’s fully integrated operations supporting the development and commercialization of the company’s antibodies, according to an ImClone statement.

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