Clinical Fill-Finish Suite Renovation

Project Overview

DCBA managed all aspects of procurement, construction, commissioning, and validation for a clinical fill-finish suite renovation in an occupied manufacturing space, coordinating shutdowns to tie-in critical utilities and meet patient clinical trial deadlines. The renovation included architectural, process, and utility upgrades, along with the installation of new equipment such as a depyrogenation oven, vial washer, freezers, and a particle monitoring system for a lyophilizer. DCBA successfully completed the project on schedule, meeting all regulatory and process needs to the client’s satisfaction.