The custom-built parenteral manufacturing facility includes three cGMP manufacturing suites, and a formulation lab and pilot suite. Features include passive restrictive access barrier system (RABS) for filling, dedicated air-handling in each suite, and video surveillance to view product development in real time.
“In addition to our 25-year history providing analytical CMC support, our offering of parenteral manufacturing services completes a seamless outsourcing solution for our pharmaceutical drug and device clients,” said marketing vice president Eric Hoffman. The Irvine campus, made up of three facilities, totals more than 75,000 sq. ft. of cGMP laboratories and manufacturing space.