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Application Notes Supplement 2021
Here, industry experts share their research, guidance and pharmaceutical knowledge.
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Endotoxin Detection
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Recombinant bacterial endotoxin testing techniques shown to be inferior
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
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Guide to Testing
Welcome to European Pharmaceutical Review’s Guide to Testing. In this edition, Associates of Cape Cod Intl Inc., Nelson Labs and SGS Health Science showcase their unique testing services and discuss how they stand out from the competition.
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Application note: Industry pushes back on USP draft chapter
Outlining the most common comments from drug manufacturers, the Parenteral Drug Association (PDA) and US Food and Drug Administration (FDA) on the USP draft chapter for recombinant Factor C ().
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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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European Pharmacopoeia publishes new chapter regarding BET testing
The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
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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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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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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.
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Video: ENDONEXT™ The evolution of endotoxin testing
With Recombinant Factor C (rFC), we’re making Endotoxin testing faster, easier and more ecologically friendly by mimicking nature, not exploiting it.
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Analytical method transfer and the supplier change processes for bacterial endotoxin testing
Changes to lab setups become necessary for many reasons, but the important role of quality control should remain consistently accurate. Tim Sandle and Kerry Skinner describe the details to consider when transferring an analytical method between laboratories or when changing your reagent supplier.
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Your endotoxin experts
Specialising in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc.
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On-demand webinar: Introducing PyroMAT- The Only Cell-line Based MAT Kit Available on the Market
Testing for pyrogens is a critical step in ensuring the safety of parenteral pharmaceutical products and medical devices.
