Authored by Tim Sandle, BPL, and Laure Robert, Merck, this report considers risk contamination coming from non-endotoxin pyrogens (NEP). Risk assessment of NEP is discussed and advantages of the Monocyte Activation Test (MAT), as opposed to the Rabbit Pyrogen Test or the BET, are explored.
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Charles River’s Endosafe^® portfolio of FDA-licensed products for bacterial endotoxin testing is designed to increase data integrity compliance, reduce retest rates, and streamline manufacturing processes, allowing prompt, confident decisions.
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In this episode, Laure Robert (Global Product Manager with Merck KGaA Darmstadt, Germany) emphasizes the importance of pyrogen testing with MAT as a final release test, gives reasons for geographical differences in MAT standardization, and describes how to implement MAT in the lab, step-by-step.
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Modern QC testing includes traditional and sustainable methods that can be automated. Lonza’s expert support and complete testing portfolio provide your laboratory versatile solutions to meet your current and future pyrogen and endotoxin testing needs.
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Successful Monocyte Activation Testing (MAT) of all parenteral pharmaceuticals, biologicals and medical devices; market leading assay sensitivity (LoD 0.004 EU/ml); 2,500 vials per PBMC batch; successful LER effect curbing; worldwide GMP certified MAT services.
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BIPEA offers three PT programs - Purified water for pharma applications: Endotoxins and TOC in purified water, Residual solvents in excipient: Ethylene oxide and Dioxane in Polyethylene glycol, Microbiology of pharmaceutical process water: total viable aerobic count in water.
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With over a century of combined research experience, FUJIFILM and Wako Chemicals U.S.A. continue the development of products that can improve human health and protect the environment. See the complete line of Wako LAL products at wakopyrostar.com
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This whitepaper compares the performance of LAL reagents with rFC, and shows the evidence supporting the 10 reasons to choose recombinant horseshoe crab Factor C (rFC) for your bacterial endotoxin testing.
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