Harvesting the Benefits of LEAN in Biopharmaceutical Manufacturing - Practical examples of how LEAN was implemented in Novartis's biopharmaceutical manufacturing operations, showing the results achiev

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Harvesting the Benefits of LEAN in Biopharmaceutical Manufacturing
Practical examples of how LEAN was implemented in Novartis's biopharmaceutical manufacturing operations, showing the results achieved.


BioPharm International
Volume 22, Issue 10

A BROADER SCOPE, BEYOND MANUFACTURING

From LEAN Manufacturing to LEAN Enterprise

LEAN is not just about manufacturing. Its philosophy and principles can, and should, be applied to other business areas, to improve processes and teamwork by eliminating bureaucracy and silo thinking, leading to a so-called LEAN enterprise.2 A few examples we are working on are mentioned below, to illustrate the potential of LEAN and the variety of fields where it can be applied.

A LEAN Supply Chain

"LEANing" the individual facilities for API production and fill–finish, i.e., the main elements of the supply chain process, does not ensure that the whole process works in a LEAN fashion unless the "linking" process has been addressed as well. We have therefore started to apply LEAN to the entire supply chain process, from the supply of raw materials to the delivery of packaged products to the customers in the various countries for specific brands. The main benefits observed are a greater transparency and significant lead-time compression and inventory reduction, leading to higher flexibility and cost savings.

LEAN Technical Development

The technical development of biopharmaceuticals traditionally involves several steps or process versions, which leads to non-value-adding steps such as multiple technology transfers and comparability studies. We have thus started to implement a LEAN roadmap for the technical development of biopharmaceuticals, through which site transfers and comparability studies—among other things—are minimized. The main benefits are lower resource requirements, lower risk of non-comparable materials between clinical phases, and higher flexibility to support any acceleration dictated by clinical trials.

Numerous other applications in non-technical fields include HR processes and the clinical trial process.

SUMMARY

In this article we have shown how our methodology, based on a radical, systematic and relentless approach, can bring significant improvements to manufacturing operations in the field of biopharmaceuticals, with impact on the following performance factors:

  • throughput time
  • throughput rate
  • failure rate
  • overall asset effectiveness and capacity utilization.

The main business outcomes are general cost avoidance, reduction of production cost and higher flexibility. Implementing LEAN should not be a one-time project. Instead, it should be executed in several steps and may take years until it is fully embedded in an organization. For this purpose, the right people qualification program and organization must be put in place. Our innovative flat, process-oriented organization can greatly contribute to the sustainability of LEAN through the development of a culture of continuous improvement.

Thibaud S. Stoll is the head of Global Biopharmaceutical Operations and Jean-François Guilland is the head of operational excellence in global biopharmaceutical operations, both at Novartis Pharma AG, Basel, Switzerland, +41 (0)61 324 39 68,

REFERENCES

1. Liker JK. The Toyota Way. New York: McGraw-Hill, 2004.

2. Womack JP, Jones DT. Lean thinking; Banish waste and create wealth in your corporation. London: Simon & Schuster UK Ltd, revised and updated edition, 2003.

3. Junker BH. Applying operational excellence concepts to biopharmaceutical processing. BioPharm Int. 2008;21(11):54–60.

4. Altria KD, Dufton AM, Carleysmith SW. Learning from Lean Sigma. Pharm Technol Eur. 2009;21(2):16–24.

5. Capell K. Glaxo mimics carmaker to speed vaccine. Business Week. 2007 April 3.


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