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.
SUMMARY AND IMPACT
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
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
FIND ADDITIONAL TABLES ONLINE
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,
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