A Generic Growth Test Method for Improving Quality Control of Disposables in Industrial Cell Culture - Independent data, using several different cell lines and growth media, reported growth inhibition

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A Generic Growth Test Method for Improving Quality Control of Disposables in Industrial Cell Culture
Independent data, using several different cell lines and growth media, reported growth inhibition resulting from the use disposable bags and suggests a method that can be implemented for quality control at disposable-bag vendors.


BioPharm International
Volume 23, Issue 6, pp. 34-41

REFERENCES

1. A. Mire-Shis et al, BioProcess Int. 9 (2) 14-23 (2011).

2. P. Gammell, "The impact of Lot-to-lot Variability of Disposable Cell Culture Bags on Cell Growth During the Scale-Up of a Mammalian Production Cell Line: Root Cause Analysis and Lessons Learned from the Pipeline," presentation at the Cell Culture Engineering XIII Conference (Scottsdale, AZ, April 2012).

3. M. Shiratori, "Recent Experiences with Single-Use Containers Used for Media Storage, Media Handling and Cell Culture," presentation at the IBC 8th International Single-Use Applications for Biopharmaceutical Manufacturing Conference (Long Beach, CA, June 2011).

4. M. Shiratori, "Recent Experiences with Single-Use Containers Used for Media Storage, Media Handling and Cell Culture," presentation at the BioProcess International Conference & Exhibition Conference (Long Beach, CA, November 2011).

5. J. Wood, "Take II—More Findings and Updates on Our Experiences with Disposable Bags for Cell-culture media Storage," presentation at the IBC's 9th International Single-Use Applications for Biopharmaceutical Manufacturing Conference (San Francisco, CA, June 2012).

6. W. Lin and V.L. Tsang, "Risk Mitigation of Mammalian Cell Growth Issues when Using Disposable Cell Culture Bags," presentation at the 245th American Chemical Society National Meeting and Exposition (New Orleans, LA, April 2013).

7. J. Kadarusman et al, Biotechnol. Prog. 21 (4) 1341-1346 (2005).

8. D. Low, "Material Understanding and Supplier Collaboration for Single-Use Systems," presentation at the Bioprocess International Conference and Exhibitions (Providence, RI, October 2012).

9. M. Goodwin and S. Kline, "New Approaches to Managing Single-Use Systems," presentation at the 3rd Annual Single Use Bioprocess Technologies Symposium (Research Triangle Park, NC, February 2013).


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