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Your endotoxin experts
Specialising in chromogenic and turbidimetric reagent technologies, ACC has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 45 years.
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Endotoxin
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Expert view: The right endotoxin detection solution for you – bioMérieux’s complete portfolio of rFC endotoxin assays
As part of any general pyrogen testing strategy, the detection of even minute traces of the highly pyrogenic bacterial molecule called lipopolysaccharide (LPS, also named endotoxin) in pharmaceutical samples is mandatory to ensure patient safety.
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The analytical reality of recombinant endotoxin technologies
29 July 2020 | By Charles River
In this webinar we discuss the results of our latest study where we evaluated the ruggedness, repeatability and specificity of commercially available rFC products, as well as our own recombinant product in development, against a large panel of endotoxins.
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Brochure: Sievers Eclipse: Compliant, consistent, conscious bacterial endotoxin testing
The Sievers Eclipse* Bacterial Endotoxins Testing (BET) Platform empowers users to be conscious of today’s needs to protect valuable natural resources while still complying with the strict analytical and regulatory requirements drug and device manufacturers must meet.
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The impact of supply chain risks and LAL reliance
For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL). This article addresses the potential risks associated with relying on a single raw material in a fragile supply chain and explores alternative testing options.
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Product hub: Sievers Eclipse Bacterial Endotoxins Testing Platform
To fulfil the need for compliant, efficient endotoxin testing that the horseshoe crab population can sustain, SUEZ introduces the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform.
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European Pharmaceutical Review Issue 3 2020
In this issue is a discussion on the promise of virally vectored DNA and mRNA vaccines to combat COVID-19 as well as articles on how packaging could help to ensure patient adherence, regulatory issues for medicines and diagnostics during the pandemic and the benefits of digitalising the pharmaceutical supply chain.…
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Video: Vanquish core video infographic
The Vanquish Core is a powerful system designed for dependability whilst giving you exceptional results in an intuitive and easy to use instrument.
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Infographic: Eight reasons to use Thermo Scientific for HPLC
Separate your science from the status quo, advanced solutions offering superior retention time stability, flexible integration and minimal maintenance.
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Brochure: Thermo Scientific Charged Aerosol Detectors
Charged aerosol detection is a technique capable of measuring any non-volatile and many semi-volatile species in a pharmaceutical applications.
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On-demand webinar: Microbiological control in a pharmaceutical manufacturing environment
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
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Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
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Comprehensive consultation, validation, training and support
As the pioneers of the Limulus amebocyte lysate (LAL) testing methodology, Associates of Cape Cod, Inc. (ACC) specialises in bacterial endotoxin and (1→3)-ß-D-glucan detection, using US Food and Drug Administration-licensed chromogenic, turbidimetric and gel-clot reagent technologies.
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Expert view: Improving the endotoxin test paradigm established by LAL
THE ADVANTAGES of the recombinant Factor C (rFC) test lie in its (a) scientific characterisation, (b) sustainability and (c) specificity. In light of diminishing horseshoe crab populations, sustainability has been mandated via regulations that include the concept of the “3 Rs”: replacement, reduction and refinement of analytical tests and reagents…
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General chapter on the rFC test adopted by the European Pharmacopoeia Commission
The recombinant Factor C (rFC) assay has been developed to help alleviate the pressures of a growing demand for the Limulus amoebocyte lysate (LAL) assay. Here, Sven Deutschmann and Johannes Reich discuss the advantages of rFC and its recent recognition by the European Pharmacopoeia as an alternative endotoxin test.
