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news.ImClone Systems, a biopharmaceutical company, has received approval from the FDA for its 'BB50' manufacturing facility to manufacture multiple biologic products.
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This approval expands ImClone’s total available production volume capacity for its proprietary pipeline of novel antibodies, which are now entering late-stage clinical development.
ImClone’s 250,000sqft multi-suite BB50 facility has previously received FDA approval to manufacture Erbitux. Together with the company’s ‘BB36’ manufacturing facility, ImClone has a total production volume capacity of up to 140,000 liters at its Branchburg, New Jersey campus.
Richard Crowley, senior vice president of biopharmaceutical operations at ImClone, said: “This multi-product FDA approval of BB50 significantly enhances ImClone’s operational flexibility as we scale up production of our pipeline of proprietary antibodies for the growing number of Phase II and Phase III trials that will be commencing in 2009.”