Isolation and characterization of the environmental bacterial and fungi contamination in a pharmaceutical unit of mesenchymal stem cell for clinical use

Biologicals

Volumn 40, Issue 5, 2012, Pages 330-337

  Martín, Patricia Gálvez ^a   González, María Bermejo ^a   Martínez, Adolfina Ruiz ^b   Lara, Visitación Gallardo ^b   Naveros, Beatriz Clares ^b  

^a CABIMER Andalusian Center for Molecular Biology and Regenerative Medicine CSIC University of Seville UPO   (Spain)

^b UNIVERSITY OF GRANADA   (Spain)

Author keywords

Cell factory; Cell therapy; Environmental microbiology; Mesenchymal stem cell

Indexed keywords

AIR SAMPLING; ARTICLE; ASPERGILLUS; BACILLUS; BACTERIAL GROWTH; BACTERIUM CONTAMINATION; BACTERIUM IDENTIFICATION; BACTERIUM ISOLATION; CLADOSPORIUM; CONTROLLED STUDY; DRUG MANUFACTURE; ENVIRONMENTAL MONITORING; FUNGAL CONTAMINATION; FUNGUS GROWTH; FUNGUS IDENTIFICATION; FUNGUS ISOLATION; GRAM NEGATIVE BACTERIUM; GRAM POSITIVE BACTERIUM; HUMAN; HUMAN CELL; HUMIDITY; KOCURIA; MATERIALS HANDLING; MESENCHYMAL STEM CELL; MICROCOCCUS; NONHUMAN; PENICILLIUM; PRIORITY JOURNAL; PRODUCT SAFETY; QUALITY CONTROL; SEASONAL VARIATION; STAPHYLOCOCCUS; SUMMER; WINTER;

AIR MICROBIOLOGY; BACTERIA; CELL SEPARATION; CELLS, CULTURED; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; DRUG CONTAMINATION; ENVIRONMENT; ENVIRONMENTAL MONITORING; FUNGI; HUMANS; MESENCHYMAL STEM CELL TRANSPLANTATION; MESENCHYMAL STROMAL CELLS; MICROBIOLOGICAL TECHNIQUES; PHARMACEUTICAL PREPARATIONS; SPECIMEN HANDLING;

ASPERGILLUS; BACILLUS (BACTERIUM); BACTERIA (MICROORGANISMS); CLADOSPORIUM; FUNGI; KOCURIA; PENICILLIUM; STAPHYLOCOCCUS;

EID: 84865626294     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2012.06.002     Document Type: Article

References (44)

1. Strong M., Farrugia A., Rebulla P. Stem cell and cellular therapy developments. Biologicals 2009, 37:103-107.
2. Nguyen P.K., Lan F., Wang Y., Wu J.C. Imaging: guiding the clinical translation of cardiac stem cell therapy. Circ Res 2011, 109:962-979.
3. Terzic A., Edwards B.S., McKee K.C., Nelson T.J. Regenerative medicine: a reality of stem cell technology. Minn Med 2011, 94:44-47.
4. Umezawa A., Miyamoto Y. Regenerative medicine, cell therapy and stem cells. Nippon Jibiinkoka Gakkai Kaiho 2011, 114:593-601.
5. Liras A. Future research and therapeutic applications of human stem cells: general, regulatory, and bioethical aspects. J Transl Med 2010, 8:131.
6. Parson A.B. Stem cell biotech: seeking a piece of the action. Cell 2008, 132:511-513.
7. Weber W.A. Brown adipose tissue and nuclear medicine imaging. J Nucl Med 2004, 45:1101-1103.
8. Caorsi P.B., Sakurada Z.A., Ulloa M.T., Pezzani V.M., Latorre O.P. Bacteriological quality of air in a ward for sterile pharmaceutical preparations. Rev Chilena Infectol 2011, 28:14-18.
9. Lehec S.C. Microbiological monitoring of hepatocyte isolation in the GMP laboratory. Methods Mol Biol 2009, 481:221-227.
10. Favero M.S., Puleo J.R., Marshall J.H., Oxborrow G.S. Comparative levels and types of microbial contamination detected in industrial clean rooms. Appl Microbiol. 1966, 14:539-551.
11. Doblhoff-Dier O., Stacey G.N. Cell lines: applications and biosafety. Biological safety: principles and practice 2009, 290-325. ASM Press, Washington DC. 5th ed. D.O. Flemmings, D.L. Hunt (Eds.).
12. Cobo F., Concha A. Environmental microbial contamination in a stem cell bank. Lett Appl Microbiol 2007, 44:379-386.
13. Cobo F., Grela D., Concha A. Airborne particle monitoring in clean room environments for stem cell cultures. Biotechnol J 2008, 3:43-52.
14. Stacey G.N. Cell culture contamination. Methods Mol Biol 2011, 731:79-91.
15. Sterility. European pharmacopeia 2008, Section 2.6.1, Maisonneuve S.A., Sainte Ruffine. 6th ed.
16. Penfornis P., Pochampally R. Isolation and expansion of mesenchymal stem cells/multipotential stromal cells from human bone marrow. Methods Mol Biol 2011, 698:11-21.
17. Mirjalili A., Parmoor E., Bidhendi S.M., Sarkari B. Microbial contamination of cell cultures: a 2 years study. Biologicals 2005, 33:81-85.
18. Stacey G.N., Auerbach J.M. Quality control procedures for stem cell lines. Culture of human stem cells 2007, 1-22. John Wiley & Sons, New Jersey. R.I. Freshney, G.N. Stacey, J.M. Auerbach (Eds.).
19. Environmental contamination control practice 2002, Parenteral Society Technical Monograph No. 2, Parenteral Society, London.
20. Andersen A. New sampler for the collection, sizing and enumeration of viable airbone particles. J Bacteriol 1958, 76:471-484.
21. White W. Sterility assurance and models for assessing bacterial contamination. J Parenter Sci Technol 1995, 40:188-197.
22. European Commission The rules governing medicinal products in the European Union, EudraLex [accessed 15.01.12]. http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm.
23. Pitt J.I., Hocking A. Fungi and food spoilage 1997, Blakie Academic and Professional, London. 2nd ed.
24. Hoog G.S., Guarro J., Gené J., Figueras M.J. Atlas of clinical fungi 2000, Centraalbureau voor Schimmelcultures, Ultercht, Universitat Rovira i Virgili, Reus. 2nd ed.
25. European Commission The rules governing medicinal products in the European Union, annex 1, Eudralex [accessed 15.01.12]. http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm.
26. Delorme B., Chateauvieux S., Charbord P. The concept of mesenchymal stem cells. Regen Med 2006, 1:497-509.
27. Williams A.R., Hare J.M. Mesenchymal stem cells: biology, pathophysiology, translational findings, and therapeutic implications for cardiac disease. Circ Res 2011, 109:923-940.
28. Phinney D.G., Prockop D.J. Concise review: mesenchymal stem/multipotent stromal cells: the state of transdifferentiation and modes of tissue repair. Stem Cells 2007, 25:2896-2902.
29. Brooke G., Cook M., Blair C., Han R., Heazlewood C., Jones B., et al. Therapeutic applications of mesenchymal stromal cells. Semin Cell Dev Biol 2007, 18:846-858.
30. Kollar K., Seifried E., Henschler R. Therapeutic potential of intravenously administered human mesenchymal stromal cells. Hamostaseologie 2011, 31:269-274.
31. Daikeler T., Tyndall A. Stem cell treatment of autoimmune disease. Dtsch Med Wochenschr 2011, 136:1684-1686.
32. Knezevic I., Stacey G.N., Petricciani J.P., Sheets R. Evaluation of cell substrates for the production of biological: revision of WHO recommendations. Biologicals 2010, 38:162-169.
33. Coecke S., Balls M., Bowe G., Davis J., Gstraunthaler G., Hartung T., et al. Guidance on good cell culture practice: a report of the second ECVAM task force on good cell culture practice. Altern Lab Anim 2005, 33:261-287.
34. Nelson-Rees W.A., Daniels D.W., Flandermeyer R.R. Cross-contamination of cells in culture. Science 1981, 212:446-452.
35. Mason C., Manzotti E. The industry responsible for cell-based therapies. Regen. Med 2009, 4:783-785.
36. Cobo F., Stacey G.N., Hunt C., Cabrera C., Nieto A., Montes R., et al. Microbiological control in stem cell banks: approaches to standardisation. Appl Microbiol Biotechnol 2005, 68:456-466.
37. Ottria G., Dallera M., Aresu O., Manniello M.A., Parodi B., Spagnolo A.M., et al. Environmental monitoring programme in the cell therapy facility of a research centre: preliminary investigation. J Prev Med Hyg 2010, 51:133-138.
38. Frommer W., Archer L., Boon L., Brunius G., Collins C.H., Crooy P., et al. Safe biotechnology recommendations for safe work with animal and human cell cultures concerning potential human pathogens. Appl Microbiol Biotechnol 1993, 39:141-147.
39. Koneman E.W., Allen S.D., Janda W.M., Schreckenberger P.C., Winn W.C. Diagnostic microbiologic 1999, Panamericana, Buenos Aires. 5th ed.
40. Sheraba N.S., Yassin A.S., Amin M.A. High-throughput molecular identification of Staphylococcus spp. isolated from a clean room facility in an environmental monitoring program. BMC Res Notes 2010, 4:278.
41. White W., Bailey P.V. Reduction of microbial dispersion by clothing. J Parenter Sci Technol 1985, 39:51-61.
42. Underwood E. Ecology of microorganisms as it affects the pharmaceutical industry. Pharmaceutical microbiology 1992, 353-368. Blackwell Scientific, London. 5thj ed. W.B. Hugo, A.D. Russell (Eds.).
43. Grant C., Hunter C., Flanningan B., Bravery A. The moisture requirements of moulds isolated from domestic dwellings. Int Biodeterior 1989, 25:259-284.
44. Byrns G., Fuller T.P. The risks and benefits of chemical fumigation in the health care environment. J Occup Environ Hyg 2011, 8:104-112.