Harvesting the Benefits of LEAN in Biopharmaceutical Manufacturing

The LEAN manufacturing and management model, developed from the Toyota Production System (TPS), has triggered major transformations in various manufacturing industries. Implementation in the field of biopharmaceuticals, however, has been limited to date. We believe that properly implementing LEAN in biopharmaceutical manufacturing can bring huge benefits, despite the complexity of biotechnology and the stringent regulatory requirements. In this article, we provide practical examples to highlight the areas where such benefits can be achieved. We also describe our qualification concept and the implementation of a new flat and crossfunctional process-oriented organization in manufacturing sites, in line with TPS principles, to ensure the development of a "LEAN" culture-a culture of continuous improvement.