Roche has opened a new state-of-the-art clinical supply manufacturing facility on its campus in Nutley, N.J. The Roche Center of Excellence produces dosage forms of highly potent compounds for preclinical safety studies, and phase I and II clinical studies. The 17,000 square foot facility houses specialized equipment to process potent compounds into medicines for clinical trials.
"This is a vitally important milestone for the Nutley site as well as pharmaceutical research and early development at Roche," said Waseem Malick, PhD, vice president, pharmaceutical & analytical R&D. "It enables continued support of our portfolio, and is another example of Roche's commitment to Nutley as a major research center for Roche."
Plans for the facility were approved in May 2010 and construction began in August 2010. The clinical dosage forms produced by the facility include tablets, capsules, powders, suspensions and solutions. Scientists and engineers manufacture clinical supplies of highly active compounds under current Good Manufacturing Practices (cGMP) for Roche trials worldwide. It also contains warehouses for components, excipients (inactive ingredients) and active pharmaceutical ingredients (APIs), mechanical rooms and multipurpose isolation suites for manufacturing.