Simple strategies to improve bioprocess pure culture processing

Pharmaceutical Engineering

Volumn 30, Issue 3, 2010, Pages

  Hines, Michael ^a,b,c   Holmes, Chris ^a,d,e   Schad, Ryan ^a,f,g,h  

^a ELI LILLY AND COMPANY   (United States)

^b MICHIGAN STATE UNIVERSITY   (United States)

^c BUTLER UNIVERSITY   (United States)

^d UNIVERSITY OF IOWA   (United States)

^e DRAKE UNIVERSITY   (United States)

^f EASTMAN CHEMICAL COMPANY   (United States)

^g PURDUE UNIVERSITY   (United States)

^h Eli Lilly and Company's MCC/Fermentation Bioprocess Pilot Plant ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ELASTOMER;

BACTERIUM CONTAMINATION; BIOLOGICAL MONITORING; BIOPROCESS; CULTURE TECHNIQUE; DEVICE; DISPOSABLE EQUIPMENT; ELECTRONIC SENSOR; EQUIPMENT DESIGN; FERMENTATION; FILTER; INSTRUMENT STERILIZATION; MEDICAL LITERATURE; MICROBIAL CONTAMINATION; PRESSURE; REVIEW; RISK REDUCTION;

EID: 79952491652     PISSN: 02738139     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (21)

1. Baseman, H.J., "SIP/CIP Validation," Pharmaceutical Engineering, March/April 1992, Vol. 12, No. 2, www.ispe.org.
2. Richards, J.W, Introduction to Industrial Sterilization, London and New York: Academic Press, 1968.
3. Agalloco, J.P and Carleton, F.J., (Editors), Validation of Pharmaceutical Processes (3rd Ed.), New York: Informa Healthcare USA, Inc., 2008.
4. Mullin, R., "Plastics Revolution in Bioprocessing," Chemical and Engineering News, Vol. 85, No. 23, 2007.
5. Nelson, K. L., "Implementing Single-Use Systems in Existing Facilities," Pharmaceutical Manufacturing, Volume 7, Issue 2, 2008.
6. Boehm, J. and Bushnell, B., "Contamination Prevention: How Single-Use Systems Can Ensure a Safe, Clean, and Efficient Bioprocess Environment," PharmTech.com (Pharmaceutical Technology online), June 2, 2008.
7. Langer, E.S., "Batch Failure Rates in Biomanufacturing," Genetic Engineering and Biotechnology News, Vol. 28, No. 14, 2008.
8. Shaw, J.L. and S.A. Rogers, "Succeed at Bioprocess Scale-Up," Chemical Processing, Vol. 69, Issue 9, 2006.
9. Alexander, C.W., "FMEA:ARisk-BasedApproachtoSterility Assurance," Pharmaceutical Manufacturing, Volume 6, Issue 1, 2007.
10. Clement, L. and Ames, H., "Steam Sterilization Failure Investigation: A Systemic Line of Attack," Healthcare Purchasing News, Vol. 29, No. 9, 2005.
11. Shanley A., "Chiron's Curse," Pharmaceutical Manufacturing, Volume 4, Issue 1, 2005.
12. Junker, B., et al., "Sustainable Reduction of Bioreactor Contamination in an Industrial Fermentation Pilot Plant," Journal of Bioscience and Bioengineering, Vol. 102, No. 4, 2006.
13. Ozturk, S.S. and Hu, W., (Editors), Cell Culture Technology for Pharmaceutical and Cell-Based Therapies, New York and London: Taylor and Francis Group, 2006.
14. Chisti, Y., "Assure Bioreactor Sterility," Chem. Engr. Prog., Vol. 88, No. 9, 1992.
15. Clippinger, M. (Editor), Industrial Biotechnology: A Training Manual, Cincinnati:Thomson Learning Custom Publishing, 2001.
16. International Standard ISO #10156, "Gases and Gas Mixtures - Determination of Fire Potential and Oxidizing Ability for the Selection of Cylinder Valve Outlets," First Edition, 15 December 1990.
17. Langer, E.S. (Editor), 6th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, Rockville Maryland: BioPlan Associates, Inc., 2009.
18. Chisti, Y. and Moo-Young, M., "Fermentation Technology, Bioprocessing, Scale-Up, and Manufacture," Biotechnology: The Science and the Business, Moses, V, and Cape, R.E., (Editors), p. 167, New York: Harwood Academic Publishers, 1991.
19. Perkowski, C.A., "Operational Aspects of Bioreactor Contamination Control," Journal of Parent. Sci. Technol., Vol., 44, 1990.
20. Bartholomew, W.H., et al., "Reduction of Contamination in an Industrial Fermentation Plant," Biotechnol. Bioengineering, Vol. 16, 1974.
21. Brooks, C.H. and Russell, PH., "A Unifed Design Approach to Fermentor Sterility and Containment," Process Biochem., Vol. 21, 1986.