Developing a Lean approach to biopharmaceutical processes


This chapter discusses how to build an holistic approach to operating a Lean manufacturing process. It covers the Current State/Future State transition of the manufacturing process and the integration of the QC laboratory aspects of the overall process. It covers key considerations including standardized work, development of work cells, use of cross-functional teams, and waste reduction. In dealing with this, issues such as approaches to ‘right first time’, failure rates, training and the use of metrics are discussed and useful examples are given. In relation to metrics, there is a focus on what is being measured and why. The keys to project success are highlighted and some ...

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