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

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


BioPharm International
Volume 21, Issue 11

7. Womack J. The meaning of Lean. Lean Directions. Soc Manuf Eng. 2008 Jan 7. http://www.sme.org/cgi-bin/get-ewsletter.pl?LEAN&20080107&l&ID=08MG1/.

8. Puich M. Biopharmaceutical operations excellence—2006 and beyond. Biopharm Int. 2006;19(3):30–32.

9. Shanley A. Merck's Lean mission. Pharm Manufacturing. 2006; 5(1):23–25.

10. Waurzyniak P. Automation in Lean manufacturing. Manufacturing Eng. 2007;139(1):99–105.

11. Rumpf D, Wiggs G, Williams T, Worachek J. Robust, producible design process evolution. Quality Eng. 2007;19(3):171–178.

12. Research and Technology Executive Council; Corp Exec Board. Establishing a Lean R&D organization. Issue Brief. Washington, DC: Research and Technology Executive Council. 2006 September.

13. Johnson R, Yu O, Kirdar AO, Annamalai A, Ahuga S, Ram K, Rathore AS. Applications of multivariate data analysis in biotech processing. Biopharm Int. 2007;20(10): 130–144.

14. Pawlicki T, Mundt AJ. Quality in radiation oncology. Med. Phys. 2007;34(5):1529–1534.

15. Suri R, Sahu S, Rath F. Using QRM to reduce lead times in biotech manufacturing. Industrial Engineering Annual Conference and Exhibition. 2006 May; Orlando, FL.

16. Junker B, Wang HY. Bioprocess monitoring and computer control: Key roots of the current PAT initiative. Biotechnol. Bioeng. 2006;95(2):226–261.

17. Shankar R, Frapaise X, Brown B. LEAN drug development in R&D. Drug Discov Develop. 2006;9(5):57–60.

18. Weber A. Automation dos and don'ts. Assembly. 2007;50(9):26-37.

19. Miller G, Scott C. Running fast, running Lean: Upgrading the bioprocessing machine. BioProcess Int. 2007;5 (S6):14–19.

20. Puich M. Optimizing Efficiency. Biopharm Int. 2007;20(7):34-35.

21. Best M, Neuhauser D. Walter A Shewhart, 1924, and the Hawthorne factory. Qual. Saf. Health Care. 2006;15:42–143

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

23. Kamarck M. In the quest to manage capacity, biology trumps stainless steel. BioPharm Int. 2007;20(9):78.

24. Kamarck ME, Hann LE, Adamson SR. Biotech manufacturing grows up. BioPharm Int. 2007;20(10): 159–164.

25. Wrankmore M. Applying continuous improvement (CI) to manufacturing. Biopharm Int. 2004;17:56–58.

26. Greene A, O'Rourke D. Lean manufacturing practice in a cGMP environment. Pharm Technol Europe. 2006;18(10):33–39.

27. Fleming JH, Coffman C, Harter JK. Manage your human sigma. Harvard Business Rev. 2005 July/August;107–114.

28. Brogan JW. Improving Lean Six Sigma process with Lean Six Sigma. 2007 Oct 29. http://www.isixsigma.com/

29. Stom B. Flexible manufacturing in the fight against generic erosion. Innov Pharm Technol. 2007;23:92–97.

30. Tyson TC. Pharmaceutical manufacturing innovation. J Pharm Innov. 2007;2:37–50.


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