FDA gave new 250,000-sq-ft site a thumbs up.
ImClone Systems received approval from the FDA for a second facility to manufacture Erbitux®. This 250,000 sq-ft building, referred to as BB50, more than doubles the production volume capacity for the drug, according to ImClone.
Construction of BB50 was completed in the fourth quarter of 2005. The plant is designed to contain three distinct suites with a total future production volume capacity of up to 110,000 L. The commissioning and initial validation of one of the suites was completed during the second quarter of 2006, and the company began producing Erbitux in this suite in June 2006.
The other two suites at this site will enable ImClone to produce Erbitux, additional ImClone drugs, or third-party products under contract manufacturing agreements.