Robust Experimental Strategies for Improving Upstream Productivity - Identify the best experimentation methods for the data you need. - BioPharm International

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Robust Experimental Strategies for Improving Upstream Productivity
Identify the best experimentation methods for the data you need.


BioPharm International
Volume 23, Issue 7

REFERENCES

1. International Conference on Harmonization. Q8, pharmaceutical development, current step 4 version. Geneva, Switzerland, 2005 Nov.

2. Snee RD, Cini P, Kamm JJ, Meyers C. Quality by Design—shortening the path to acceptance. Pharm Process. 2008;25(3): 20–24.

3. Snee RD. Quality by Design—four years and three myths later. Pharm Process. 2009;2:14–16.

4. Snee RD. Building a framework for Quality by Design. Pharm Tech. Online exclusive; 2009 Oct. Available from: http://pharmtech.findpharma.com/pharmtech/Special+Section%3a+Quality+by+Design/Building-a-Framework-for-Quality-by-Design/ArticleStandard/Article/detail/632988

5. Hulbert MH, Feely LC, Inman EL, Johnson AD, Kearney AS, Michaels J, Mitchell M, Zour E. Risk management in pharmaceutical product development. J Pharm Innovation. 2008;3:227–48.

6. Lonardo A, Snee RD, B Qi. Time value of information in design of downstream purification processes—getting the right data in the right amount at the right Time. BioPharm Int. Advances in separation and purification: the future of downstream processing. 2010 Mar suppl; pp. 29–34.

7. Snee RD. Raising your batting average. Remember the importance of strategy in experimentation. Qual Prog. 2009;12:64–8.

8. Yan L, Le-he M. Optimization of fermentation conditions for P450 BM-3 monooxygenase production by hybrid design methodology. J Zhejian Univ Sci B. 2007;8(1):27–32.

9. Kamm JJ, Heilman C. Coming to a biotech near you: Quality by Design Part 2: design space in development and manufacturing. BioPharm Int. 2008;21(7):24–30.

10. Box GEP, Hunter JS, Hunter WG. Statistics for experimenters—design, innovation and discovery. New York, NY: Wiley-Interscience; 2005.

11. Schweitzer M, Pohl M, Hanna-Brown M, Nethercote P, Borman P. Hanson G, Smith K, Larew J. Implications and opportunities of applying QbD principles to analytical measurements. Position paper: QbD analytics. Pharm Tech. 2010;34(2):52–9.

12. King PL. Lean for the process industries. Boca Raton, FL: CRC Press; 2009.

13. Kamm JJ, Villarrubia Y. Using Lean principles to improve analytical laboratory operations. Personal Communication with the author; 2009.


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