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WO2004046375A3 - Method for the detection of microorganisms in pharmaceutical products - Google Patents

Method for the detection of microorganisms in pharmaceutical products Download PDF

Info

Publication number
WO2004046375A3
WO2004046375A3 PCT/EP2003/012505 EP0312505W WO2004046375A3 WO 2004046375 A3 WO2004046375 A3 WO 2004046375A3 EP 0312505 W EP0312505 W EP 0312505W WO 2004046375 A3 WO2004046375 A3 WO 2004046375A3
Authority
WO
WIPO (PCT)
Prior art keywords
detection
pharmaceutical products
microbial contaminant
cosmetics
microorganisms
Prior art date
Application number
PCT/EP2003/012505
Other languages
French (fr)
Other versions
WO2004046375A2 (en
Inventor
Cecilia Dazzi
Volker Eck
Luca Cantelli
Adrian Harri
Peter Brodmann
Ralf Seyfarth
Original Assignee
Pharmacia Italia Spa
Cecilia Dazzi
Volker Eck
Luca Cantelli
Adrian Harri
Peter Brodmann
Ralf Seyfarth
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pharmacia Italia Spa, Cecilia Dazzi, Volker Eck, Luca Cantelli, Adrian Harri, Peter Brodmann, Ralf Seyfarth filed Critical Pharmacia Italia Spa
Priority to AU2003288018A priority Critical patent/AU2003288018A1/en
Priority to EP03779871A priority patent/EP1565576A2/en
Publication of WO2004046375A2 publication Critical patent/WO2004046375A2/en
Publication of WO2004046375A3 publication Critical patent/WO2004046375A3/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/04—Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6888—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms
    • C12Q1/689—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria

Landscapes

  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

The present invention discloses a method for the detection and identification of living microbial contaminant cells in pharmaceutical products, pharmaceutical production environments, cosmetics and food. The method of the invention is based on the selective amplification by quantitative PCR of specific target cDNA sequences, in particular sequences encoding ribosomal RNA of the microbial contaminant to be detected.The invention also provides for a test kit for the detection and identification of living microbial contaminant cells in pharmaceutical products, pharmaceutical production environments, cosmetics and food comprising primers and probes specific for a ribosomal RNA target gene of the microbial contaminant.
PCT/EP2003/012505 2002-11-20 2003-11-07 Method for the detection of microorganisms in pharmaceutical products WO2004046375A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2003288018A AU2003288018A1 (en) 2002-11-20 2003-11-07 Method for the detection of microorganisms in pharmaceutical products
EP03779871A EP1565576A2 (en) 2002-11-20 2003-11-07 Method for the detection of microorganisms in pharmaceutical products

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US42755402P 2002-11-20 2002-11-20
US60/427,554 2002-11-20

Publications (2)

Publication Number Publication Date
WO2004046375A2 WO2004046375A2 (en) 2004-06-03
WO2004046375A3 true WO2004046375A3 (en) 2004-12-23

Family

ID=32326561

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2003/012505 WO2004046375A2 (en) 2002-11-20 2003-11-07 Method for the detection of microorganisms in pharmaceutical products

Country Status (3)

Country Link
EP (1) EP1565576A2 (en)
AU (1) AU2003288018A1 (en)
WO (1) WO2004046375A2 (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2021513B1 (en) 2006-05-12 2011-06-29 Gen-Probe Incorporated Compositions and methods to detect enterococci nucleic acid
AT504194B1 (en) 2006-09-07 2008-07-15 Oesterr Rotes Kreuz BACTERIA DETECTION
US7595164B2 (en) 2007-12-26 2009-09-29 Gen-Probe Incorporated Compositions and methods to detect Candida albicans nucleic acid
ES2327703B1 (en) * 2008-04-30 2010-07-07 Universidad Del Pais Vasco METHODS AND REAGENTS FOR THE DETECTION OF SALMONELLA SP.
WO2009158119A2 (en) 2008-05-30 2009-12-30 Gen-Probe Incorporated Compositions, kits and related methods for the detection and/or monitoring of salmonella
CN101363061B (en) * 2008-10-07 2011-08-10 华中农业大学 Fluorescent quantitative PCR method by using taqman probe for detecting salmonella in food
WO2011109901A1 (en) * 2010-03-10 2011-09-15 The Governors Of The University Of Alberta Detection and quantification of viable bacteria in a sample using rpos mrna
US10392670B2 (en) 2013-07-25 2019-08-27 Dch Molecular Diagnostics, Inc. Methods and compositions for detecting bacterial contamination
US11608516B2 (en) 2015-04-15 2023-03-21 Ecolab Usa Inc. Method for determination of diversity and viability thresholds used to assess microorganisms in process samples
US20210332419A1 (en) * 2018-09-26 2021-10-28 Adaptive Phage Therapeutics, Inc. Monitoring host cell contamination of virus-based biological products
CN111763669B (en) * 2020-02-10 2021-06-15 澳门科技大学 Double-stranded RNA molecule and application thereof
US20240240262A1 (en) * 2022-12-22 2024-07-18 Trace-Ability, Inc. Viable cell detection and protocol implementing the same

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999058713A2 (en) * 1998-05-12 1999-11-18 Bioinside Gmbh Method for detecting microorganisms in products
WO2001057055A2 (en) * 2000-01-31 2001-08-09 GSF-Forschungszentrum für Umwelt und Gesundheit GmbH Oligonucleotides for specific amplification and specific detection of 16s rrna genes from bacteria
WO2002010444A1 (en) * 2000-07-28 2002-02-07 University Of Sydney A method of detecting microorganisms
US6472149B1 (en) * 1996-10-28 2002-10-29 Compagnie Gervais Danone Method for detecting live microbiological contaminants in a food product sample

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6472149B1 (en) * 1996-10-28 2002-10-29 Compagnie Gervais Danone Method for detecting live microbiological contaminants in a food product sample
WO1999058713A2 (en) * 1998-05-12 1999-11-18 Bioinside Gmbh Method for detecting microorganisms in products
WO2001057055A2 (en) * 2000-01-31 2001-08-09 GSF-Forschungszentrum für Umwelt und Gesundheit GmbH Oligonucleotides for specific amplification and specific detection of 16s rrna genes from bacteria
WO2002010444A1 (en) * 2000-07-28 2002-02-07 University Of Sydney A method of detecting microorganisms

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
MCKILLIP J L ET AL: "rRNA stability in heat-killed and UV-irradiated enterotoxigenic Staphylococcus aureus and Escherichia coli O157:H7.", APPLIED AND ENVIRONMENTAL MICROBIOLOGY. NOV 1998, vol. 64, no. 11, November 1998 (1998-11-01), pages 4264 - 4268, XP002296971, ISSN: 0099-2240 *
SHERIDAN G E C ET AL: "DETECTION OF MRNA BY REVERSE TRANSCRIPTION-PCR AS AN INDICATOR OF VIABILITY IN ESCHERICHIA COLI CELLS", APPLIED AND ENVIRONMENTAL MICROBIOLOGY, WASHINGTON,DC, US, vol. 64, no. 4, April 1998 (1998-04-01), pages 1313 - 1318, XP000870176, ISSN: 0099-2240 *
YARON S ET AL: "A reverse transcriptase-polymerase chain reaction assay for detection of viable Escherichia coli O157:H7: investigation of specific target genes.", JOURNAL OF APPLIED MICROBIOLOGY. 2002, vol. 92, no. 4, April 2002 (2002-04-01), pages 633 - 640, XP002296970, ISSN: 1364-5072 *

Also Published As

Publication number Publication date
AU2003288018A1 (en) 2004-06-15
EP1565576A2 (en) 2005-08-24
AU2003288018A8 (en) 2004-06-15
WO2004046375A2 (en) 2004-06-03

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