Biomanufacturing is moving towards higher efficiency through process intensification. One aspect of intensification is achieving operational excellence by connecting unit operations and running the process functionally closed. The advantages of closed processing are shorter processing time, less manual interactions in the process, reduced CAPEX, reduced resources for cleaning and validation, and reduced need for qualified manufacturing space.
Closed connected processing, however, poses new challenges with respect to process development, planning, and execution. This white paper reviews the benefits and challenges with closed processing and connected processing. By giving examples for the implementation of closed, connected processing in large-scale manufacturing, you will be able to explore and assess options that work for your objectives.