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Methods of Microbial Identification During Drug Quality Analysis and Applicability Assessment

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Pharmaceutical Chemistry Journal Aims and scope

Rapid and correct identification of microorganisms is an essential part of pharmaceutical analysis. Several phenotypic, genotypic, and proteotypic methods, each of which has its own advantages and limitations, are currently used to identify microorganisms. The aim of the present work was to reveal features and validate the operation of a Vitek 2 Compact 30 bacteriological analyzer (bioMerieux, France), which was based on determining the biochemical properties of microorganisms. The applicability of this method was determined using accuracy, precision, and robustness. Correct results were found in 86% of 396 cases. Results obtained under repeatability and intermediate precision conditions showed no differences. Approaches to molecular and genetic identification of microorganisms isolated from preparations in addition to automated biochemical identification were discussed.

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References

  1. O. V. Gunar, N. G. Sakhno, M. V. Roshchina, V. E. Grigor?eva, et al., Vedom. NTsESMP, 4, 7 – 11 (2014); O. V. Gunar, N. G. Sakhno, M. V. Roshchina, et al., Sci. Centre Expert Eval. Med. Prod. Bull., 4, 7 – 11 (2014).

  2. R. A. Volkova, E. S. Skolotneva, E. V. Elbert, et al., BIOprep. Profil. Diagn. Lech., No. 2, 9 – 14 (2015); R. A. Volkova, E. S. Skolotneva, E. V. Elbert, et al., BIOprep. Prev. Diagn. Treat., No. 2, 9 – 14 (2015); https: // doi.org / 10.30895 /2221-996X-2015-2-9-14.

  3. D. S. Davydov, M. P. Rudnik, A. A. Movsesyants, et al., BIOprep. Profil. Diagn. Lech., No. 4, 52 – 58 (2015); D. S. Davydov, M. P. Rudnik, A. A. Movsesyants, et al., Bioprep. Prev. Diagn. Treat., No. 4, 52 – 58 (2015); https: //doi.org / 10.30895 / 2221-996X-2015-4-52-58.

  4. The United States Pharmacopeia, 40th Ed., The United States Pharmacopeial Convention, Rockville, MD (2017).

  5. J. Hakovirta, Modern Techniques in Detection, Identification and Quantification of Bacteria and Peptides from Foods, Helsinki (2008).

  6. L. Li, N. Mendis, H. Trigui, et al., Front. Microbiol., 5, Article 258 (2014).

  7. T. Sandle, Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control, Woodhead Publishing, UK (2015).

  8. G. Funke, D. Monnet, C. de Bernardis, et al., J. Clin. Microbiol., 36(7), 1948 – 1952 (1998).

    CAS  PubMed  PubMed Central  Google Scholar 

  9. S. Q. van Veen, E. C. Claas, and E. J. Kuijper, J. Clin. Microbiol., 48, 900 – 907 (2010).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. P. C. Schreckenberger, K. L. Ristow, and A. M. Krilcich, Comparison of the Vitek legacy, Vitek 2 colorimetric and Phoenix systems for identification of fermenting and non-fermenting bacteria of clinical origin, 105th General Meeting of the American Society for Microbiology, USA (2005).

  11. U. Eigner, A. Schmid, U. Wild, D. Bertsch, et al., J. Clin. Microbiol., 43(8), 3829 – 3834 (2005).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. L. Guo, L. Ye, Q. Zhao, et al., J. Thorac. Dis., 6(5), 534 – 538 (2014).

  13. C. M. O’Hara, F. C. Tenover, and J. M. Miller, J. Clin. Microbiol., 31(12), 3165 – 3169 (1993).

  14. J. A. Odumeru, M. Steele, L. Fruhner, et al., J. Clin. Microbiol., 37(4), 944 – 949 (1999).

    CAS  PubMed  PubMed Central  Google Scholar 

  15. S. Sutton, Am. Pharm. Rev., 15(6), 36 – 48 (2012).

  16. FDA. Bacteriological Analytical Manual (BAM), 8th Ed., Rev. A; URL:http: // www.fda.gov / Food / FoodScienceResearch /LaboratoryMethods / ucm2006949.htm.

  17. S. M. Tallent, K. M. Kotewicz, E. A. Strain, and R. W. Bennett, J. AOAC Int., 95(2), 446 – 451 (2012).

    Article  CAS  PubMed  Google Scholar 

  18. N. J. Tourasse, O. A. Okstad, and A. B. Kolsto, Database (2010), Article ID baq017; DOI:10.1093 / database / baq017.

  19. A. Sorokin, B. Candelon, K. Guilloux, et al., Appl. Environ. Microbiol., 72(2), 1569 – 1578 (2006).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  20. M. Sebaihia, M. W. Peck, N. P. Minton, et al., Genome Res., 17(7), 1082 – 1092 (2007); DOI: 10.1101 / gr.6282807.

  21. S. Sutton and A. M. Cundell, Pharmacopeial Forum, 30(5), 1884 – 1894 (2004).

    Google Scholar 

  22. European Pharmacopeia, 9th Ed., Council of Europe, Strasbourg (2017).

  23. PI 0012-3. Recommendations on Sterility Testing, Secretariat of the Pharmaceutical Inspection Convention, Belgium (2007).

  24. B. Malorny, P. T. Tassios, P. Radstrom, et al., Int. J. Food Microbiol., 83, 39 – 48 (2003).

    Article  CAS  PubMed  Google Scholar 

  25. L. Jimenes, S. Smalls, and R. Ignar, J. Microbiol. Methods, 41(3), 259 – 265 (2000).

    Article  Google Scholar 

  26. K. Cankar, D. Stebih, T. Dreo, J. Zel, et al., BMC Biotechnol., 6(37), doi:10.1186 / 1472-6750-6-37 (2006).

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Acknowledgments

The work was performed in the framework of State Task for SCEEMP, Ministry of Health of Russia, No. 056-00023-18-02 for applied scientific research (State Contract No. NIR AAAA-A18-118021590049-0).

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Authors and Affiliations

  1. Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051, Russia

    O. V. Gunar & N. G. Sakhno

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  1. O. V. Gunar
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  2. N. G. Sakhno
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Correspondence to O. V. Gunar.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 52, No. 11, pp. 55 – 58, November, 2018.

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Gunar, O.V., Sakhno, N.G. Methods of Microbial Identification During Drug Quality Analysis and Applicability Assessment. Pharm Chem J 52, 942–945 (2019). https://doi.org/10.1007/s11094-019-01930-3

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  • DOI: https://doi.org/10.1007/s11094-019-01930-3

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