<abstract xmlns="http://www.w3.org/1999/xhtml"><p>Microbiological control is of crucial importance in the pharmaceutical industry regarding the possible bacterial contamination of the environment, water, raw materials and finished products. Molecular identification of bacterial contaminants based on DNA sequencing of the hypervariable 16<italic>S</italic>rRNA gene has been introduced recently. The aim of this study is to investigate the suitability of gene sequencing using our selection of PCR primers and conditions for rapid and accurate bacterial identification in pharmaceutical industry quality control.</p><p>DNA was extracted from overnight incubated colonies from 10 bacterial ATCC strains, which are common contaminants in the pharmaceutical industry. A region of bacterial 16<italic>S</italic>rRNA gene was analyzed by bidirectional DNA sequencing. Bacterial identification based on partial sequencing of the 16<italic>S</italic>rRNA gene is the appropriate method that could be used in the pharmaceutical industry after adequate validations. We have successfully identified all tested bacteria with more than 99 % similarity to the already published sequences.</p></abstract>

Microbiological control is of crucial importance in the pharmaceutical industry regarding the possible bacterial contamination of the environment, water, raw materials and finished products. Molecular identification of bacterial contaminants based on DNA sequencing of the hypervariable 16SrRNA gene has been introduced recently. The aim of this study is to investigate the suitability of gene sequencing using our selection of PCR primers and conditions for rapid and accurate bacterial identification in pharmaceutical industry quality control.DNA was extracted from overnight incubated colonies from 10 bacterial ATCC strains, which are common contaminants in the pharmaceutical industry. A region of bacterial 16SrRNA gene was analyzed by bidirectional DNA sequencing. Bacterial identification based on partial sequencing of the 16SrRNA gene is the appropriate method that could be used in the pharmaceutical industry after adequate validations. We have successfully identified all tested bacteria with more than 99 % similarity to the already published sequences.

Optimized genotyping method for identification of bacterial contaminants in pharmaceutical industry

Quality Assurance, Profit Center Pharmaceuticals, Alkaloid AD, Skopje, Republic of Macedonia

Laboratory for Molecular Biology, Institute of Biology, Faculty of Natural Sciences and Mathematics, Ss. Cyril & Methodius University, Skopje, Republic of Macedonia

Acta Pharmaceutica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Microbiological control is of crucial importance in the pharmaceutical industry regarding the possible bacterial contamination of the environment, water, raw...

Optimized genotyping method for identification of bacterial contaminants in pharmaceutical industry

Published Online: May 28, 2016

Page range: 289 - 295

Accepted: Oct 13, 2015

DOI: https://doi.org/10.1515/acph-2016-0011

Keywords
16rRNA, genotyping, bacterial identification, pharmaceutical industry

© 2016 Borche Stamatoski et al., published by De Gruyter Open

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Optimized genotyping method for identification of bacterial contaminants in pharmaceutical industry

Published Online: May 28, 2016

Page range: 289 - 295

Accepted: Oct 13, 2015

DOI: https://doi.org/10.1515/acph-2016-0011

Keywords16rRNA, genotyping, bacterial identification, pharmaceutical industry

© 2016 Borche Stamatoski et al., published by De Gruyter Open

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
16rRNA, genotyping, bacterial identification, pharmaceutical industry