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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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Endotoxin
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Expert view: Automation in endotoxin testing: new applications using recombinant horseshoe crab Factor C (rFC) reagents with robotics
Sustainable reagents based on recombinant horseshoe crab Factor C (rFC) provides advances in endotoxin testing.
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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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Quality control solutions that fuel confident decisions
As the partner of choice for managing microbial quality control, Charles River’s products and services facilitate confident and objective decision-making, ensuring the integrity of your microbial data, reducing risk, building efficiency and improving your bottom line, while assisting in the journey to bring products to market.
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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.
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Whitepaper: Monocyte activation test (MAT)
For pharmaceutical companies, patient safety has always been the priority. That’s why pyrogen detection has become a mandatory Quality Control test for release of any parenteral drug.
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Expert view: Low Endotoxin Recovery (LER)
The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topic of Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue, as well as to analytical and mitigation strategies.
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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 FDA-licensed chromogenic, turbidimetric and gel-clot reagent technologies.
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Endotoxin definition and standardisation
Appropriate standards for impurity tests are an important part of analytical testing. In this paper, Kevin Williams outlines various requirements of standards for endotoxin, as stated by United States Pharmacopeia (USP), and elaborates on the definition of endotoxin as distinct from other cellular constituents.
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Charles River microbial solutions
Those who work in QC know that the job is more than a box to be checked, and that it can’t be done effectively without confidence in the reported results. Tight timelines, regulatory demands, and stringent data integrity standards can make it hard to focus on what’s really at stake…
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Expert View: Advancing bacterial endotoxin testing with recombinant Factor C
Emerging recombinant Factor C (rFC) methods have many advantages to offer pharmaceutical quality control, including improved specificity, robustness, efficiency and alignment with 3R principles. First, global manufacturers have validated rFC and pharmacopoeias worldwide are on the move. Here, Karolina Heed provides an industry and regulatory update.
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Whitepaper: ENDOZYME II GO recombinant Factor C assay: fast, easy and consistent endotoxin testing
Microplate-based standard endotoxin tests require time-consuming manual handling steps, the results of which are by no means conclusive. Read how the GO PLATE - part of ENDOZYME II GO - helps to address these issues.
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European Pharmaceutical Review Issue 2 2019
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
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Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
