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Low Endotoxin Recovery – Masking of Naturally Occurring Endotoxin

Low Endotoxin Recovery – Masking of Naturally Occurring Endotoxin

Endotoxins are cell wall components of Gram-negative bacteria. A release of endotoxins into the human blood stream results in an inflammation reaction that can lead to life-threatening conditions like sepsis. Therefore, control for endotoxin contamination of intravenously administered drugs is crucial.

Drugs are usually tested for putative endotoxin contamination with Limulus-based tests. However, validity of the compendial test procedures is questioned in the case of low endotoxin recovery (LER).

To assure validity, regulatory authorities request hold-time studies of endotoxin in addition to pharmacopoeial requirements. Within these studies, endotoxin is added (spiked) to an undiluted product. The spiked product is held for a certain period of time and subsequently diluted for endotoxin determination. Due to the known heterogeneity of endotoxin the question has been raised as to which source represents the most adequate endotoxin spike.

In the present study, endotoxin hold-time studies were analyzed by using different sources of endotoxin. Highly purified endotoxin, crude endotoxin extracts (Naturally Occurring Endotoxin) from different bacterial species and varied growth conditions as well as endogenous endotoxin contaminations were investigated.

The results clearly demonstrate that endotoxin masking – an effect of LER – is dependent on the endotoxin source used. Various parameters such as bacterial strain and growth conditions lead to different masking susceptibilities. Due to these effects it is impossible to predict the susceptibility of bacterial endotoxin contamination to LER. In order to determine whether a sample is prone to LER, an endotoxin spike that is susceptible to LER is required.

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  • 07Okt

    Job- und Ausbildungsmesse 14.10.2021 11:00 Uhr bis 21:00 Uhr in der Tiefenstollenhalle Peißenberg

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  • 29Sep

    Job- und Ausbildungsmesse 05.10.2021 11:30 Uhr bis 21:00 Uhr in der Stadthalle Penzberg

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  • 14Mai

    Digitale Jobmesse 2021 der Hochschule Biberach

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  • 04Mai

    Geschützt: ECA Monocyte Activation Test (MAT)

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  • 28Apr

    Geschützt: ECA Low Endotoxin Recovery/Masking

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  • 03Feb

    Meet us at the Pharmaceutical Microbiology East Coast conference – Boston, USA

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  • 25Nov

    Low Endotoxin Recovery/Masking Training Course Munich/Bernried, GERMANY

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  • 25Nov

    2nd Monocyte-Activation-Test proficiency test program, 13./14. Februar 2020

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  • 21Okt

    Meet us at the PharmaLab 2019 Düsseldorf/Neuss, Germany

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  • 23Sep

    Mikrobiologie-Konferenz, 01./02. Oktober 2019 – Mannheim

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Meet us at the 14th Annual Biomarkers Congress 2019

Meet us at the 14th Annual Biomarkers Congress 2019

Dr. Patricia Wolf will be presenting a poster about ultra-sensitive biomarker quantification methods at the 14th Annual Biomarkers Congress 2019

21 – 22 February 2019, Manchester, UK

Click here for more informations: 14th Annual Biomarkers Congress 2019, Manchester

MORE EVENTS
  • 07Okt

    Job- und Ausbildungsmesse 14.10.2021 11:00 Uhr bis 21:00 Uhr in der Tiefenstollenhalle Peißenberg

    Read More →
  • 29Sep

    Job- und Ausbildungsmesse 05.10.2021 11:30 Uhr bis 21:00 Uhr in der Stadthalle Penzberg

    Read More →
  • 14Mai

    Digitale Jobmesse 2021 der Hochschule Biberach

    Read More →
  • 04Mai

    Geschützt: ECA Monocyte Activation Test (MAT)

    Read More →
  • 28Apr

    Geschützt: ECA Low Endotoxin Recovery/Masking

    Read More →
  • 03Feb

    Meet us at the Pharmaceutical Microbiology East Coast conference – Boston, USA

    Read More →
  • 25Nov

    Low Endotoxin Recovery/Masking Training Course Munich/Bernried, GERMANY

    Read More →
  • 25Nov

    2nd Monocyte-Activation-Test proficiency test program, 13./14. Februar 2020

    Read More →
  • 21Okt

    Meet us at the PharmaLab 2019 Düsseldorf/Neuss, Germany

    Read More →
  • 23Sep

    Mikrobiologie-Konferenz, 01./02. Oktober 2019 – Mannheim

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The Endotoxin-Service announces the succesful participation on the LAL PTP study B18

The Endotoxin-Service announces the succesful participation on the LAL PTP study B18

The Endotoxin-Service announces the successful participation on the LAL PTP study B18.

With this result we can look back on 5 years of successful LAL PTP studies.

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  • 07Okt

    Job- und Ausbildungsmesse 14.10.2021 11:00 Uhr bis 21:00 Uhr in der Tiefenstollenhalle Peißenberg

    Read More →
  • 29Sep

    Job- und Ausbildungsmesse 05.10.2021 11:30 Uhr bis 21:00 Uhr in der Stadthalle Penzberg

    Read More →
  • 14Mai

    Digitale Jobmesse 2021 der Hochschule Biberach

    Read More →
  • 04Mai

    Geschützt: ECA Monocyte Activation Test (MAT)

    Read More →
  • 28Apr

    Geschützt: ECA Low Endotoxin Recovery/Masking

    Read More →
  • 03Feb

    Meet us at the Pharmaceutical Microbiology East Coast conference – Boston, USA

    Read More →
  • 25Nov

    Low Endotoxin Recovery/Masking Training Course Munich/Bernried, GERMANY

    Read More →
  • 25Nov

    2nd Monocyte-Activation-Test proficiency test program, 13./14. Februar 2020

    Read More →
  • 21Okt

    Meet us at the PharmaLab 2019 Düsseldorf/Neuss, Germany

    Read More →
  • 23Sep

    Mikrobiologie-Konferenz, 01./02. Oktober 2019 – Mannheim

    Read More →
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Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

PharmaLab

Düsseldorf/Neuss, Germany

20 – 21. November 2018

https://www.pharmalab-kongress.de/

MORE EVENTS
  • 07Okt

    Job- und Ausbildungsmesse 14.10.2021 11:00 Uhr bis 21:00 Uhr in der Tiefenstollenhalle Peißenberg

    Read More →
  • 29Sep

    Job- und Ausbildungsmesse 05.10.2021 11:30 Uhr bis 21:00 Uhr in der Stadthalle Penzberg

    Read More →
  • 14Mai

    Digitale Jobmesse 2021 der Hochschule Biberach

    Read More →
  • 04Mai

    Geschützt: ECA Monocyte Activation Test (MAT)

    Read More →
  • 28Apr

    Geschützt: ECA Low Endotoxin Recovery/Masking

    Read More →
  • 03Feb

    Meet us at the Pharmaceutical Microbiology East Coast conference – Boston, USA

    Read More →
  • 25Nov

    Low Endotoxin Recovery/Masking Training Course Munich/Bernried, GERMANY

    Read More →
  • 25Nov

    2nd Monocyte-Activation-Test proficiency test program, 13./14. Februar 2020

    Read More →
  • 21Okt

    Meet us at the PharmaLab 2019 Düsseldorf/Neuss, Germany

    Read More →
  • 23Sep

    Mikrobiologie-Konferenz, 01./02. Oktober 2019 – Mannheim

    Read More →
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We now offer affordable ultra-sensitive biomarker detection with Simoa™ technology

We now offer affordable ultra-sensitive biomarker detection with Simoa™ technology

We are proud to announce that we now offer an exciting immunoassay platform to our customers that opens up new horizons in biomarker analysis. As one of the very first in Europe we have introduced the benchtop Simoa™ Quanterix SR-X™ Biomarker Detection System.

Simoa™ is a single molecule digital detection technology that represents a platform for multiplexed detection of up to 6 biomarkers per sample. It provides ultra-sensitive detection capabilities, while it remains just as affordable as a regular ELISA assay. Additionally, low volume requirements conserve precious samples. The SR-X™ traps and isolates individual immunocomplexes on paramagnetic beads in thousands of femtoliter-sized wells on a disposable disc. Only one single molecule is needed to obtain a suitable fluorescence signal.

Not only does Quanterix offer over 70 commercially available Simoa kits, the SR-X™ also enables fast assay development tailored to our customers’ demands for both circulating proteins and nucleic acids from blood, without complex pre-analytical extraction and PCR. Customers can rely on our extensive expertise in the development of bead-based assays.

Thus, no matter whether you desire exploratory routine sample measurements or seek to develop novel assays of great efficiency, we can offer the implementation of a vast variety of large molecule assays on Simoa™ technology. The SR-X™ enables us to detect biomarkers with an unparalleled sensitivity, 1000x higher than standard immunoassay methods with high precision across a range of sample types and according to highest quality standards.

MORE EVENTS
  • 07Okt

    Job- und Ausbildungsmesse 14.10.2021 11:00 Uhr bis 21:00 Uhr in der Tiefenstollenhalle Peißenberg

    Read More →
  • 29Sep

    Job- und Ausbildungsmesse 05.10.2021 11:30 Uhr bis 21:00 Uhr in der Stadthalle Penzberg

    Read More →
  • 14Mai

    Digitale Jobmesse 2021 der Hochschule Biberach

    Read More →
  • 04Mai

    Geschützt: ECA Monocyte Activation Test (MAT)

    Read More →
  • 28Apr

    Geschützt: ECA Low Endotoxin Recovery/Masking

    Read More →
  • 03Feb

    Meet us at the Pharmaceutical Microbiology East Coast conference – Boston, USA

    Read More →
  • 25Nov

    Low Endotoxin Recovery/Masking Training Course Munich/Bernried, GERMANY

    Read More →
  • 25Nov

    2nd Monocyte-Activation-Test proficiency test program, 13./14. Februar 2020

    Read More →
  • 21Okt

    Meet us at the PharmaLab 2019 Düsseldorf/Neuss, Germany

    Read More →
  • 23Sep

    Mikrobiologie-Konferenz, 01./02. Oktober 2019 – Mannheim

    Read More →
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The changing environment in pyrogen and endotoxin testing

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Low Endotoxin Recovery/Masking Training Munich/Bernried, Germany

Low Endotoxin Recovery/Masking Training Munich/Bernried, Germany

Low Endotoxin Recovery/Masking Training, Munich/Bernried, Germany (27-28. February 2018)

https://www.gmp-compliance.org/training/gmp-course-conference/low-endotoxin-recovery-masking

MORE NEWS
  • 07Okt

    Job- und Ausbildungsmesse 14.10.2021 11:00 Uhr bis 21:00 Uhr in der Tiefenstollenhalle Peißenberg

    Read More →
  • 29Sep

    Job- und Ausbildungsmesse 05.10.2021 11:30 Uhr bis 21:00 Uhr in der Stadthalle Penzberg

    Read More →
  • 14Mai

    Digitale Jobmesse 2021 der Hochschule Biberach

    Read More →
  • 04Mai

    Geschützt: ECA Monocyte Activation Test (MAT)

    Read More →
  • 28Apr

    Geschützt: ECA Low Endotoxin Recovery/Masking

    Read More →
  • 03Feb

    Meet us at the Pharmaceutical Microbiology East Coast conference – Boston, USA

    Read More →
  • 25Nov

    Low Endotoxin Recovery/Masking Training Course Munich/Bernried, GERMANY

    Read More →
  • 25Nov

    2nd Monocyte-Activation-Test proficiency test program, 13./14. Februar 2020

    Read More →
  • 21Okt

    Meet us at the PharmaLab 2019 Düsseldorf/Neuss, Germany

    Read More →
  • 23Sep

    Mikrobiologie-Konferenz, 01./02. Oktober 2019 – Mannheim

    Read More →
READ MORE

Press release: HRP2 recombinant panel now available for malaria rapid diagnostic tests

Press release: HRP2 recombinant panel now available for malaria rapid diagnostic tests

Press release: HRP2 recombinant panel now available for malaria rapid diagnostic tests

Microcoat and the Foundation for Innovative New Diagnostics (FIND) announce the launch of HRP2 recombinant panel for assessment of the malaria rapid diagnostic test performance in product evaluation and lot testing programs

Read the full press release here:

Microcoat-FIND_press release_04.09.2017-final

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Microcoat now offering Assay Development and Sample Measurement on MSD® Platform

Microcoat now offering Assay Development and Sample Measurement on MSD® Platform

Microcoat expands its technological portfolio by Meso Scale Discovery´s Electrochemiluminescence (MSD-ECL) platform. Based on non-radioactive electrochemiluminescent labels for ultra-sensitive detection, MSD yields higher sensitivity and broader dynamic range compared to ELISA technology. Microcoat offers development of assays from the scratch as well as transfer of classical ELISA formats in addition to method comparison, validation and sample measurement.  Customers profit from our year-long experience in custom-fit optimization and manufacturing of antibody conjugates including MSD´s SULFO-Tag®.

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Microcoat announces the launch of WATSON bioanalytical LIMS

Microcoat announces the launch of WATSON bioanalytical LIMS

Microcoat´s Laboratory Services announces launch of Thermo Scientific™ Watson™ bioanalytical LIMS V. 7.5

For clinical and pre-clinical drug development support, the right LIMS can accelerate sample turnaround, improve operational efficiency and drive quality and compliance.

Microcoat selected Thermo Scientific™ Watson LIMS™, a bioanalytical LIMS installed in 18 of the top 20 global pharmaceutical organizations and widely used in leading biotechnology and contract research organizations worldwide. Watson LIMS™ facilitates efficient study design and data transfer while streamlining assay validation, bioanalysis, instrument interfacing, sample tracking, results reporting and regulatory compliance.

With Watson LIMS™ Version 7.5 we obtained the latest version which also supports assay validation studies. The system is fully validated to meet all relevant requirements for the support of regulated PK and Immunogenicity studies.

All sample management activities will be transferred from existing systems into Watson LIMS to ensure full traceability from sample reception through analysis to long-term storage. Starting from the implementation of microplate readers, we subsequently plan to integrate more technology platforms (MSD©, Cobas©, ELLA©) to further improve and streamline our workflows.

Thermo Scientific™ Watson LIMS™ software is specifically designed and built to support the bioanalytical workflow, allowing to:

  • Manage both small and large molecule workflows in a single solution
  • Harmonize laboratory processes across all sites
  • Ease exchange of information between sponsors and contract labs
  • Increase throughput by automating data handling and reporting tasks
  • Promote compliance throughout the workflow
  • Implement quantitative concentration assays or qualitative immunogenicity assays
  • Track study sample history from receipt to disposal
  • Comply with SOPs and reduce the risk of non-compliance” (www.thermofisher.com)
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