메뉴 건너뛰기




Volumn 6, Issue 3, 2004, Pages 183-195

Comparison of automated culture systems with a CFR/USP-compliant method for sterility testing of cell-therapy products

Author keywords

Cell therapy products; Somatic cell therapy; Sterility testing

Indexed keywords

ANTIBIOTIC AGENT;

EID: 3042808738     PISSN: 14653249     EISSN: None     Source Type: Journal    
DOI: 10.1080/14653240410005997     Document Type: Article
Times cited : (36)

References (30)
  • 1
    • 0000835959 scopus 로고    scopus 로고
    • Suitability determination for donors of human cellular and tissue-based products; Proposed rule
    • US Food and Drug Administration
    • US Food and Drug Administration. Suitability determination for donors of human cellular and tissue-based products; Proposed rule. Federal Register 1999;64:52696-723.
    • (1999) Federal Register , vol.64 , pp. 52696-52723
  • 2
    • 84879106279 scopus 로고    scopus 로고
    • US Food and Drug Administration. General Biologics Standards. 21 CFR 600
    • US Food and Drug Administration. General Biologics Standards. 21 CFR 600.
  • 3
    • 84879088154 scopus 로고    scopus 로고
    • The new regulatory environment for cellular therapy products: Challenges for academic-based manufacturing facilities
    • Smit Sibinga CTh, de Leij LFMH, editors. Boston: Kluwer Academic Publishers
    • Read EJ. The new regulatory environment for cellular therapy products: challenges for academic-based manufacturing facilities. In: Smit Sibinga CTh, de Leij LFMH, editors. Cellular engineering and cellular therapies. Boston: Kluwer Academic Publishers, 2003.
    • (2003) Cellular Engineering and Cellular Therapies
    • Read, E.J.1
  • 4
    • 0142094685 scopus 로고    scopus 로고
    • Current regulatory issues in cell and tissue therapy
    • Burger S. Current regulatory issues in cell and tissue therapy. Cytotherapy 2003;5:289-98.
    • (2003) Cytotherapy , vol.5 , pp. 289-298
    • Burger, S.1
  • 5
    • 84879078012 scopus 로고    scopus 로고
    • US Food and Drug Administration. General Biologics Standards, 21 CFR 610.12
    • US Food and Drug Administration. General Biologics Standards. 21 CFR 610.12.
  • 6
    • 84879123442 scopus 로고    scopus 로고
    • US Pharmacopeia. General Information Chapter 71, Sterility Tests, Rockville, MD
    • US Pharmacopeia. General Information Chapter 71, Sterility Tests, Rockville, MD 2003.
    • (2003)
  • 8
    • 0031693289 scopus 로고    scopus 로고
    • Use of the BacT/Alert blood culture system for culture of sterile body fluids other than blood
    • Bourbeau P, Riley J, Heiter BJ et al. Use of the BacT/Alert blood culture system for culture of sterile body fluids other than blood. J Clin Microbiol 1998;36:3273-7.
    • (1998) J. Clin. Microbiol. , vol.36 , pp. 3273-3277
    • Bourbeau, P.1    Riley, J.2    Heiter, B.J.3
  • 9
    • 0034007106 scopus 로고    scopus 로고
    • Evaluation of the BacT/Alert microbial detection system with FAN aerobic and FAN anaerobic bottles for culturing normally sterile body fluids other than blood
    • Simor AE, Scythes K, Meaney H et al. Evaluation of the BacT/Alert microbial detection system with FAN aerobic and FAN anaerobic bottles for culturing normally sterile body fluids other than blood. Diagn Microbiol Infect Dis 2000;37:5-9.
    • (2000) Diagn. Microbiol. Infect. Dis. , vol.37 , pp. 5-9
    • Simor, A.E.1    Scythes, K.2    Meaney, H.3
  • 10
    • 0031415791 scopus 로고    scopus 로고
    • Comparison of Bactec Plus Aerobic/F, Anaerobic/F, Peds Plus/F, and Lytic/F media with and without fastidious organism supplement to conventional methods for culture of sterile body fluids
    • Fuller DD, Davis TE. Comparison of Bactec Plus Aerobic/F, Anaerobic/F, Peds Plus/F, and Lytic/F media with and without fastidious organism supplement to conventional methods for culture of sterile body fluids. Diagn Microbiol Infect Dis 1997;29:219-25.
    • (1997) Diagn. Microbiol. Infect. Dis. , vol.29 , pp. 219-225
    • Fuller, D.D.1    Davis, T.E.2
  • 12
    • 0031579976 scopus 로고    scopus 로고
    • Red cell transfusions contaminated with Yersinia enterocolitica - United States, 1991 - 1996, and initiation of a national study to detect bacteria-associated transfusion reactions
    • Red cell transfusions contaminated with Yersinia enterocolitica - United States, 1991 - 1996, and initiation of a national study to detect bacteria-associated transfusion reactions. MMWR 1997; 46:553-5.
    • (1997) MMWR , vol.46 , pp. 553-555
  • 13
    • 0027512209 scopus 로고
    • Effectiveness of resins in removing antibiotics from blood cultures
    • Crepin O, Roussel-Delvallez M, Martin GR et al. Effectiveness of resins in removing antibiotics from blood cultures. J Clin Microbiol 1993;31:734-5.
    • (1993) J. Clin. Microbiol. , vol.31 , pp. 734-735
    • Crepin, O.1    Roussel-Delvallez, M.2    Martin, G.R.3
  • 14
    • 0019411943 scopus 로고
    • In vitro antibiotic removal and bacterial recovery from blood with an antibiotic removal device
    • Lindsey NJ, Riely PE. In vitro antibiotic removal and bacterial recovery from blood with an antibiotic removal device. J Clin Microbiol 1981;13:503-7.
    • (1981) J. Clin. Microbiol. , vol.13 , pp. 503-507
    • Lindsey, N.J.1    Riely, P.E.2
  • 15
    • 0020645113 scopus 로고
    • In vitro evaluation of the Bactec resin-containing blood culture bottle
    • Smith SM, Eng RK. In vitro evaluation of the Bactec resin-containing blood culture bottle. J Clin Microbiol 1983;17:1120-6.
    • (1983) J. Clin. Microbiol. , vol.17 , pp. 1120-1126
    • Smith, S.M.1    Eng, R.K.2
  • 16
    • 0031755656 scopus 로고    scopus 로고
    • Effectiveness of resins in neutralizing antibiotic activities in Bactec Plus Aerobic/F culture media
    • Spaargaren J, van Boven CPA, Voorn GP. Effectiveness of resins in neutralizing antibiotic activities in Bactec Plus Aerobic/F culture media. J Clin Microbiol 1998;36:3731-3.
    • (1998) J. Clin. Microbiol. , vol.36 , pp. 3731-3733
    • Spaargaren, J.1    van Boven, C.P.A.2    Voorn, G.P.3
  • 17
    • 0023881045 scopus 로고
    • Bacterial contamination of bone marrow grafts intended for autologous and allogeneic bone marrow transplantation
    • Rowley SD, Davis J, Dick J et al. Bacterial contamination of bone marrow grafts intended for autologous and allogeneic bone marrow transplantation. Transfusion 1988;28:109-12.
    • (1988) Transfusion , vol.28 , pp. 109-112
    • Rowley, S.D.1    Davis, J.2    Dick, J.3
  • 18
    • 0025734047 scopus 로고
    • Adverse reactions in patients transfused with cryopreserved marrow
    • Stroncek DF, Fautsch DK, Lasky LC et al. Adverse reactions in patients transfused with cryopreserved marrow. Transfusion 1991;31:512-26.
    • (1991) Transfusion , vol.31 , pp. 512-526
    • Stroncek, D.F.1    Fautsch, D.K.2    Lasky, L.C.3
  • 19
    • 0025975459 scopus 로고
    • Contamination during in vitro processing of bone marrow for transplantation: Clinical significance
    • Lazarus HM, Magalhaes-Silverman M, Fox RM et al. Contamination during in vitro processing of bone marrow for transplantation: clinical significance. Bone Marrow Transplant 1991;7:241-6.
    • (1991) Bone Marrow Transplant , vol.7 , pp. 241-246
    • Lazarus, H.M.1    Magalhaes-Silverman, M.2    Fox, R.M.3
  • 20
    • 0028339889 scopus 로고
    • Microbiologic contamination of peripheral blood stein cell autografts
    • Schwella N, Zimmermann R, Heuft HG et al. Microbiologic contamination of peripheral blood stein cell autografts. Vox Sang 1994;67:32-5.
    • (1994) Vox Sang , vol.67 , pp. 32-35
    • Schwella, N.1    Zimmermann, R.2    Heuft, H.G.3
  • 21
    • 0028924939 scopus 로고
    • Microbial contamination of harvested bone marrow and peripheral blood
    • Prince HM, Page SR, Keating A et al. Microbial contamination of harvested bone marrow and peripheral blood. Bone Marrow Transplant 1995;15:87-91.
    • (1995) Bone Marrow Transplant. , vol.15 , pp. 87-91
    • Prince, H.M.1    Page, S.R.2    Keating, A.3
  • 22
    • 0030051283 scopus 로고    scopus 로고
    • Bacterial contamination rates following processing of bone marrow and peripheral blood progenitor cell preparations
    • Padley D, Koontz F, Trigg ME et al. Bacterial contamination rates following processing of bone marrow and peripheral blood progenitor cell preparations. Transfusion 1996;36:53-9.
    • (1996) Transfusion , vol.36 , pp. 53-59
    • Padley, D.1    Koontz, F.2    Trigg, M.E.3
  • 23
    • 0029848814 scopus 로고    scopus 로고
    • Sources and sequelae of bacterial contamination of hematopoietic stem cell components: Implications for the safety of hematotherapy and graft engineering
    • Webb IJ, Coral FS, Andersen JW et al. Sources and sequelae of bacterial contamination of hematopoietic stem cell components: implications for the safety of hematotherapy and graft engineering. Tranfusion 1996;36:782-8.
    • (1996) Tranfusion , vol.36 , pp. 782-788
    • Webb, I.J.1    Coral, F.S.2    Andersen, J.W.3
  • 24
    • 0029842740 scopus 로고    scopus 로고
    • Microbiologic contamination of peripheral blood progenitor cells collected for hematopoietic cell transplantation
    • Espinosa MTF, Fox R, Creger RJ et al. Microbiologic contamination of peripheral blood progenitor cells collected for hematopoietic cell transplantation. Transfusion 1996;36:789-93.
    • (1996) Transfusion , vol.36 , pp. 789-793
    • Espinosa, M.T.F.1    Fox, R.2    Creger, R.J.3
  • 25
    • 0036926816 scopus 로고    scopus 로고
    • Catastrophic failures of freezing bags for cellular therapy products: Description, cause, and consequences
    • Khuu HM, Cowley H, David-Ocampo V et al. Catastrophic failures of freezing bags for cellular therapy products: description, cause, and consequences. Cytotherapy 2002;4:539-49.
    • (2002) Cytotherapy , vol.4 , pp. 539-549
    • Khuu, H.M.1    Cowley, H.2    David-Ocampo, V.3
  • 26
    • 0015426710 scopus 로고
    • Action of sulfated polyanions used in blood culture on lysozyme, complement and antibiotics
    • Kocka FE, Magoc T, Searcy RL. Action of sulfated polyanions used in blood culture on lysozyme, complement and antibiotics. Ann Clin Lab Sci 1972;2:470-3.
    • (1972) Ann. Clin. Lab. Sci. , vol.2 , pp. 470-473
    • Kocka, F.E.1    Magoc, T.2    Searcy, R.L.3
  • 27
    • 84879115241 scopus 로고
    • Sodium polyanethol-sulfonate (SPS) inactivation of aminoglycosides
    • Krogstad D, Murray P, Granich G et al. Sodium polyanethol-sulfonate (SPS) inactivation of aminoglycosides. Antimicrob Agents Chemother 1981;20:66-70.
    • (1981) Antimicrob. Agents Chemother. , vol.20 , pp. 66-70
    • Krogstad, D.1    Murray, P.2    Granich, G.3
  • 28
    • 0019931799 scopus 로고
    • Inactivation of penicillins by thiol broth
    • Murray P, Niles A. Inactivation of penicillins by thiol broth. J Clin Microbiol 1982;16:982-4.
    • (1982) J. Clin. Microbiol. , vol.16 , pp. 982-984
    • Murray, P.1    Niles, A.2
  • 29
    • 0035033005 scopus 로고    scopus 로고
    • Evaluation of an automated culture system for detecting bacterial contamination of platelets: An analysis with 15 contaminating organisms
    • Brecher ME, Means N, Jere CS et al. Evaluation of an automated culture system for detecting bacterial contamination of platelets: an analysis with 15 contaminating organisms. Transfusion 2001;41:477-82.
    • (2001) Transfusion , vol.41 , pp. 477-482
    • Brecher, M.E.1    Means, N.2    Jere, C.S.3
  • 30
    • 84879098437 scopus 로고    scopus 로고
    • US Pharmacopeia. General Information Chapter 1046, Cell and Gene Therapy, Rockville, MD
    • US Pharmacopeia. General Information Chapter 1046, Cell and Gene Therapy, Rockville, MD 2003.
    • (2003)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.