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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.

MORE EVENTS
  • 05Apr

    Meet us at the Lonza Endotoxin Summit, (3. – 5. June 2019)

    Read More →
  • 05Apr

    Vortrag auf dem Concept Heidelberg Lehrgang aktuelle Trends bei Endotoxin- und Pyrogentests

    Read More →
  • 22Jan

    Meet us at the 14th Annual Biomarkers Congress 2019

    Read More →
  • 21Sep

    Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

    Read More →
  • 25Mai

    Meet us at the Lonza Endotoxin Summit, (12. – 14. June 2018)

    Read More →
  • 25Mai

    Participation to job exchange at the Hochschule Biberach HBC

    Read More →
  • 27Feb

    Low Endotoxin Recovery/Masking Training Munich/Bernried, Germany

    Read More →
  • 02Nov

    Visit us at our booth at the Munich Biomarker Conference 2016

    Read More →
  • 02Nov

    Meet us at the Pharmalab 2016

    Read More →
  • 08Apr

    Meet us at the Analytica 2016

    Read More →
READ MORE

And the winner of the BOSE Headphones is…

And the winner of the BOSE Headphones is…

And the winner of the BOSE Headphones is Limulus No. 7

Please contact us at to get your price!

MORE EVENTS
  • 05Apr

    Meet us at the Lonza Endotoxin Summit, (3. – 5. June 2019)

    Read More →
  • 05Apr

    Vortrag auf dem Concept Heidelberg Lehrgang aktuelle Trends bei Endotoxin- und Pyrogentests

    Read More →
  • 22Jan

    Meet us at the 14th Annual Biomarkers Congress 2019

    Read More →
  • 21Sep

    Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

    Read More →
  • 25Mai

    Meet us at the Lonza Endotoxin Summit, (12. – 14. June 2018)

    Read More →
  • 25Mai

    Participation to job exchange at the Hochschule Biberach HBC

    Read More →
  • 27Feb

    Low Endotoxin Recovery/Masking Training Munich/Bernried, Germany

    Read More →
  • 02Nov

    Visit us at our booth at the Munich Biomarker Conference 2016

    Read More →
  • 02Nov

    Meet us at the Pharmalab 2016

    Read More →
  • 08Apr

    Meet us at the Analytica 2016

    Read More →
READ MORE

Create your own Horseshoe Crab!

Create your own Horseshoe Crab!

Win a noise cancelling head phone from BOSE!

Visit our booth at PharmaLab from 20th to 21st of November and create your own Crab out of playdough.

MORE EVENTS
  • 05Apr

    Meet us at the Lonza Endotoxin Summit, (3. – 5. June 2019)

    Read More →
  • 05Apr

    Vortrag auf dem Concept Heidelberg Lehrgang aktuelle Trends bei Endotoxin- und Pyrogentests

    Read More →
  • 22Jan

    Meet us at the 14th Annual Biomarkers Congress 2019

    Read More →
  • 21Sep

    Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

    Read More →
  • 25Mai

    Meet us at the Lonza Endotoxin Summit, (12. – 14. June 2018)

    Read More →
  • 25Mai

    Participation to job exchange at the Hochschule Biberach HBC

    Read More →
  • 27Feb

    Low Endotoxin Recovery/Masking Training Munich/Bernried, Germany

    Read More →
  • 02Nov

    Visit us at our booth at the Munich Biomarker Conference 2016

    Read More →
  • 02Nov

    Meet us at the Pharmalab 2016

    Read More →
  • 08Apr

    Meet us at the Analytica 2016

    Read More →
READ MORE

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.

MORE EVENTS
  • 05Apr

    Meet us at the Lonza Endotoxin Summit, (3. – 5. June 2019)

    Read More →
  • 05Apr

    Vortrag auf dem Concept Heidelberg Lehrgang aktuelle Trends bei Endotoxin- und Pyrogentests

    Read More →
  • 22Jan

    Meet us at the 14th Annual Biomarkers Congress 2019

    Read More →
  • 21Sep

    Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

    Read More →
  • 25Mai

    Meet us at the Lonza Endotoxin Summit, (12. – 14. June 2018)

    Read More →
  • 25Mai

    Participation to job exchange at the Hochschule Biberach HBC

    Read More →
  • 27Feb

    Low Endotoxin Recovery/Masking Training Munich/Bernried, Germany

    Read More →
  • 02Nov

    Visit us at our booth at the Munich Biomarker Conference 2016

    Read More →
  • 02Nov

    Meet us at the Pharmalab 2016

    Read More →
  • 08Apr

    Meet us at the Analytica 2016

    Read More →
READ MORE

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
  • 05Apr

    Meet us at the Lonza Endotoxin Summit, (3. – 5. June 2019)

    Read More →
  • 05Apr

    Vortrag auf dem Concept Heidelberg Lehrgang aktuelle Trends bei Endotoxin- und Pyrogentests

    Read More →
  • 22Jan

    Meet us at the 14th Annual Biomarkers Congress 2019

    Read More →
  • 21Sep

    Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

    Read More →
  • 25Mai

    Meet us at the Lonza Endotoxin Summit, (12. – 14. June 2018)

    Read More →
  • 25Mai

    Participation to job exchange at the Hochschule Biberach HBC

    Read More →
  • 27Feb

    Low Endotoxin Recovery/Masking Training Munich/Bernried, Germany

    Read More →
  • 02Nov

    Visit us at our booth at the Munich Biomarker Conference 2016

    Read More →
  • 02Nov

    Meet us at the Pharmalab 2016

    Read More →
  • 08Apr

    Meet us at the Analytica 2016

    Read More →
READ MORE

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
  • 05Apr

    Meet us at the Lonza Endotoxin Summit, (3. – 5. June 2019)

    Read More →
  • 05Apr

    Vortrag auf dem Concept Heidelberg Lehrgang aktuelle Trends bei Endotoxin- und Pyrogentests

    Read More →
  • 22Jan

    Meet us at the 14th Annual Biomarkers Congress 2019

    Read More →
  • 21Sep

    Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

    Read More →
  • 25Mai

    Meet us at the Lonza Endotoxin Summit, (12. – 14. June 2018)

    Read More →
  • 25Mai

    Participation to job exchange at the Hochschule Biberach HBC

    Read More →
  • 27Feb

    Low Endotoxin Recovery/Masking Training Munich/Bernried, Germany

    Read More →
  • 02Nov

    Visit us at our booth at the Munich Biomarker Conference 2016

    Read More →
  • 02Nov

    Meet us at the Pharmalab 2016

    Read More →
  • 08Apr

    Meet us at the Analytica 2016

    Read More →
READ MORE

Investigation of the kinetics and mechanism of low endotoxin recovery

Investigation of the kinetics and mechanism of low endotoxin recovery

The inability to detect endotoxin added to undiluted drug samples has been called: Low Endotoxin Recovery (LER). The phenomenon has caused concerns amongst drug manufacturing quality control scientists in that manufactured solutions contaminated with endotoxin could show false-negative results via routine Limulus-based tests.

The time-dependent appearance of LER has been analyzed in detail to provide a better understanding of the mechanism. The assumption has been that the root-cause of LER involves the interplay of endotoxin with surfactants and results in aggregate structures that are complexed with surfactants. The endotoxin molecules when complexed with surfactants are not accessible for Limulus-based detection.

The results demonstrate a predominant role of complex-forming agents. It was shown that although the presence of surfactants is a strong prerequisite for masking, it does not determine the kinetics of endotoxin masking. Interestingly, the endotoxin concentration itself had no substantial impact on LER kinetics. By adjusting the ratios of complex-forming constituents, including surfactant, chelator and endotoxin, and by testing the order in which the constituents are added, a new model for simulating masking kinetics has been determined. Our work provides for the first time a model to simulate masking kinetics of endotoxin which lends a better understanding of LER

MORE EVENTS
  • 05Apr

    Meet us at the Lonza Endotoxin Summit, (3. – 5. June 2019)

    Read More →
  • 05Apr

    Vortrag auf dem Concept Heidelberg Lehrgang aktuelle Trends bei Endotoxin- und Pyrogentests

    Read More →
  • 22Jan

    Meet us at the 14th Annual Biomarkers Congress 2019

    Read More →
  • 21Sep

    Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

    Read More →
  • 25Mai

    Meet us at the Lonza Endotoxin Summit, (12. – 14. June 2018)

    Read More →
  • 25Mai

    Participation to job exchange at the Hochschule Biberach HBC

    Read More →
  • 27Feb

    Low Endotoxin Recovery/Masking Training Munich/Bernried, Germany

    Read More →
  • 02Nov

    Visit us at our booth at the Munich Biomarker Conference 2016

    Read More →
  • 02Nov

    Meet us at the Pharmalab 2016

    Read More →
  • 08Apr

    Meet us at the Analytica 2016

    Read More →
READ MORE

The changing environment in pyrogen and endotoxin testing

MORE NEWS
  • 05Apr

    Meet us at the Lonza Endotoxin Summit, (3. – 5. June 2019)

    Read More →
  • 05Apr

    Vortrag auf dem Concept Heidelberg Lehrgang aktuelle Trends bei Endotoxin- und Pyrogentests

    Read More →
  • 26Mrz

    Low Endotoxin Recovery – Masking of Naturally Occurring Endotoxin

    Read More →
  • 22Jan

    Meet us at the 14th Annual Biomarkers Congress 2019

    Read More →
  • 06Dez

    And the winner of the BOSE Headphones is…

    Read More →
  • 09Nov

    Create your own Horseshoe Crab!

    Read More →
  • 02Okt

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

    Read More →
  • 21Sep

    Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

    Read More →
  • 25Mai

    Meet us at the Lonza Endotoxin Summit, (12. – 14. June 2018)

    Read More →
  • 25Mai

    Participation to job exchange at the Hochschule Biberach HBC

    Read More →
READ MORE

pLDH recombinant panels for malaria diagnostic tests

pLDH recombinant panels for malaria diagnostic tests

Press release: pLDH recombinant panels for malaria diagnostic tests

Microcoat and the Foundation for Innovative New Diagnostics (FIND) announce the launch of pLDH recombinant panels 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_launch rec panels

Find out more about the products here.

MORE NEWS
  • 05Apr

    Meet us at the Lonza Endotoxin Summit, (3. – 5. June 2019)

    Read More →
  • 05Apr

    Vortrag auf dem Concept Heidelberg Lehrgang aktuelle Trends bei Endotoxin- und Pyrogentests

    Read More →
  • 26Mrz

    Low Endotoxin Recovery – Masking of Naturally Occurring Endotoxin

    Read More →
  • 22Jan

    Meet us at the 14th Annual Biomarkers Congress 2019

    Read More →
  • 06Dez

    And the winner of the BOSE Headphones is…

    Read More →
  • 09Nov

    Create your own Horseshoe Crab!

    Read More →
  • 02Okt

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

    Read More →
  • 21Sep

    Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

    Read More →
  • 25Mai

    Meet us at the Lonza Endotoxin Summit, (12. – 14. June 2018)

    Read More →
  • 25Mai

    Participation to job exchange at the Hochschule Biberach HBC

    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

MORE NEWS
  • 05Apr

    Meet us at the Lonza Endotoxin Summit, (3. – 5. June 2019)

    Read More →
  • 05Apr

    Vortrag auf dem Concept Heidelberg Lehrgang aktuelle Trends bei Endotoxin- und Pyrogentests

    Read More →
  • 26Mrz

    Low Endotoxin Recovery – Masking of Naturally Occurring Endotoxin

    Read More →
  • 22Jan

    Meet us at the 14th Annual Biomarkers Congress 2019

    Read More →
  • 06Dez

    And the winner of the BOSE Headphones is…

    Read More →
  • 09Nov

    Create your own Horseshoe Crab!

    Read More →
  • 02Okt

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

    Read More →
  • 21Sep

    Meet us at the PharmaLab 2018 Düsseldorf/Neuss, Germany

    Read More →
  • 25Mai

    Meet us at the Lonza Endotoxin Summit, (12. – 14. June 2018)

    Read More →
  • 25Mai

    Participation to job exchange at the Hochschule Biberach HBC

    Read More →
READ MORE