Flow cytometry for the rapid detection of bacteria in cell culture production medium

Cytometry Part A

Volumn 71, Issue 12, 2007, Pages 1019-1026

  McHugh, Irene O L ^a   Tucker, Ayly Ling ^a  

^a GENENTECH INC   (United States)

Author keywords

Bacteria; Bacterial detection; Bioburden; Flow cytometry; Microbial contamination; Microbial titer; Sterile medium; Thiazole orange

Indexed keywords

EDETIC ACID; THIAZOLE ORANGE;

ANIMAL CELL; ARTICLE; BACILLUS CEREUS; BACTERIUM CULTURE; BACTERIUM DETECTION; BURKHOLDERIA CEPACIA; CONTROLLED STUDY; FLOW CYTOMETRY; MAMMAL CELL; MICROBIAL CONTAMINATION; NONHUMAN; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY;

BACTERIA; BACTERIOLOGICAL TECHNIQUES; BENZOTHIAZOLES; BIOTECHNOLOGY; COLONY COUNT, MICROBIAL; CULTURE MEDIA; FLOW CYTOMETRY; PREDICTIVE VALUE OF TESTS; QUINOLINES; SENSITIVITY AND SPECIFICITY;

EID: 36849008593     PISSN: 15524922     EISSN: 15524930     Source Type: Journal    
DOI: 10.1002/cyto.a.20488     Document Type: Article

References (20)

1. Sundaram S, Auriemma M, Howard G Jr, Brandwein H, Leo F. Application of membrane filtration for removal of diminutive bioburden organisms in pharmaceutical products and processes. J Pharm Sci Technol 1999;53:186-201.
2. Junker B, Lester M, Leporati J, Schmitt J, Kovactch M, Borysewicz S, Maciejak W, Seeley A, Hesse M, Connors N, Brix T, Creveting E, Salmon P. Sustainable reduction of bioreactor contamination in an industrial fermentation pilot plant. J Biosci Bioeng 2006;102:251-268.
3. Jorgensen JH, Jones PM. Comparative evaluation of the limulus assay and the direct gram stain for detection of significant bacteriuria. Am J Clin Pathol 1975;63:142-148.
4. Maturin LJ, Peeler JT. Aerobic plate count. Food and Drug Administration, Bacteriological Analytical Manual, 8th ed, Rev. A. Gaithersburg, MD: AOAC International; 1998. pp 3.01-3.10.
5. Davey HM. Flow cytometric techniques for the detection of microorganisms. Methods Cell Sci 2002;24:91-97.
6. Nebe-von-Caron G, Stephens PJ, Hewitt CJ, Powell JR, Badley RA. Analysis of bacterial function by multi-colour fluorescence flow cytometry and single cell sorting. J Microbiol Methods 2000;42:97-114.
7. Nohynek L, Saski E, Haikara A, Raaska L. Detection of bacterial contamination in starch and resin-based papermaking chemicals using fluorescence techniques. J Ind Microbiol Biotechnol 2003;30:239-244.
8. Hoefel D, Grooby WL, Monis PT, Andrews S, Saint CP. Enumeration of water-borne bacteria using viability assays and flow cytometry: A comparison to culture-based techniques. J Microbiol Methods 2003;55:585-597.
9. Griner PF, Mayewski, RJ, Mushlin AI, Greenland P. Selection and interpretation of diagnostic tests and procedures. Ann Intern Med 1981;94:553-660.
10. Eaton AD, Clesceri LS, Greenberg AE, editors. Standard Methods for the Examination of Water and Wastewater, 19th eds. Washington DC: American Public Health Association; 1995. pp 9-31.
11. McLaughlin J, Bruno CF, Forrest T. A rapid method for detecting bacterial contamination in the presence of Penicillium and Streptomyces antibiotic fermentations. Biotechnol Bioeng 1983;25:1229-1235.
12. Lee LG, Chen CH, Chiu LA. Thiazole orange: A new dye for reticulocyte analysis. Cytometry 1986;7:508-517.
13. Nygren J, Svanvik N, Kubista M. 1998. The interactions between the fluorescent dye thiazole orange and DNA. Biopolymers 1998;46(1):39-45.
14. Rye HS, Glazer AN. Interaction of dimeric intercalating dyes with single-stranded DNA. Nucleic Acids Res 1995;23(7):1215-1222.
15. Flowers RS, Adams DM. Spore membrane(s) as the site of damage within heated Clostridium perfringens spores. J Bacteriol 1976;125:429-434.
16. ICH Q2A. Guideline on validation of analytical procedures: Definitions and terminology. Fed Reg 1995;60:11260-11262.
17. USP 28/NF 23, United States Pharmacopeia/The National Formulary, 〈1225〉 Validation of Compendial Methods, United States Pharmacopeial Convention, Inc. Rockville, MD; 2005. p 2748-2751.
18. Yamaguchi N, Sasada M, Yamanaka M, Naus M. Rapid detection of respiring Escherichia coli O157:H7 in apple juice, milk, and ground beef by flow cytometry. Cytometry A 2003;54A:27-35.
19. Mohr H, Lambrecht B, Bayer A, Spengler HP, Nicol SB, Montag T, Muller TH. Basics of flow cytometry-based sterility testing of platelet concentrates. Transfusion 2006;46:41-49.
20. Schmidt M, Hourfar MK, Nicol SB, Spengler HP, Montag T, Seifried E. FACS technology used in a new rapid bacterial detection method. Transfus Med 2006;16:355-361.