Applying Operational Excellence Concepts to Biopharmaceutical Processing - Translate the concepts into practical application and reduce waste. - BioPharm International


Applying Operational Excellence Concepts to Biopharmaceutical Processing
Translate the concepts into practical application and reduce waste.

BioPharm International
Volume 21, Issue 11

Of course, associated risks and their mitigation should be addressed when evaluating any specific efficiency opportunity. Lean implementations must be both technically dependable and gain prompt regulatory approval.26 Table 2 shows tradeoffs (specifically probable benefits, penalties, and their mitigation) associated with the application of operational excellence solutions to biopharmaceutical processing. Analyzing these tradeoffs highlights the importance of robust and efficient data-gathering and decision-making tools when selecting and undertaking efficiency initiatives.


To maintain and improve competitiveness, successful biopharmaceutical organizations must learn to measure and manage quality.27 Operational excellence opportunities abound in biopharmaceutical processing, and can be readily framed in terms of Lean and Six Sigma concepts. These projects either reduce the organization's operating costs or increase the value of its products.28 Operational excellence improvements also can boost available capacity for sorely needed innovation by streamlining lower priority activities.

Although many initiatives are implementable within functional areas of biopharmaceutical organizations, deeper efficiency can be achieved through integrated efforts across internal and external supply chains. The internal chain links cell line/media development, upstream, downstream, manufacturing, and analytical/quality/regulatory efforts. The external value chain links vendors, government regulators, professional organizations, and academia. As with all supply chains, data visibility and prompt information flow among the components is critical for each link to understand the improvement challenge and propose suitable ideas. Integrated supply chains are necessary to attain "just-in-time" production, leading to reduced inventories, shorter lead times, and greater flexibility.29

There is extraordinary potential benefit from combining the deployment of operational excellence with process analytical technology (PAT) and Quality by Design (QbD).30,31 QbD increases process understanding, and PAT makes processes measurable and controllable in real time. Operational excellence, in turn, improves quality, raises yields, increases throughput, and lowers waste.32

Regardless of the approach taken to operational excellence, or the depth and breadth of any excellence program, the key to success lies in the continuous involvement of its people, specifically those that become the early adopters, advocates, and change agents.


See the online version of this article for three supplemental tables showing 1) More examples of how Six Sigma concepts can be applied to biopharmaceutical processing; 2) Examples of external value chains; and 3) Examples of internal value chains. These tables can be found at:

B.H. Junker is senior director of fermentation and development operations at Merck Research Laboratories Rahway, NJ, 732.594.7010,


1. Nneji B. Six sigma: Why a rifle beats a shotgun. Business Week. 2007;4038:21.

2. Julien C, Whitford W. The biopharmaceutical industry's new operating paradigm. BioProcess Int. 2008;6(S1):6–14

3. Wood, S. Lean principles of performance improvement. Innovations Pharm Technol. 2006; 20:78–80.

4. Abdulmalek FA, Rajgopal J. Analyzing the benefits of Lean manufacturing and value stream mapping via simulation: A process sector case study. Int J Production Econ. 2007;107:223–236.

5. Driscoll C. A Lean version of Lean. Contract Pharma. 2006 June.

6. DePalma A. Lean and Six Sigma approaches taking hold. Gen Eng News. 2006; 26(7):1:70–72.

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