We partnered with the customer, module provider and another engineering firm to perform the process design and CIP start-up of a new monoclonal antibody production facility. The facility included 35,000 square feet of modular clean space with cell culture and final purification suites. Extensive use of disposables in both upstream and downstream provide a flexible production area, with fully integrated and automated CIP and SIP where required. The project, including commissioning and qualification, was completed on time and under budget.
We were contracted to provide conceptual and detail process design, automation documentation, FAT support, and commissioning for the project.