Lonza’s QC Testing Solutions

Endotoxin Detection Expertise and Commitment to Sustainability For endotoxin detection, Lonza offers Limulus Amebocyte Lysate (LAL), a reagent derived from blood cells of the horseshoe crab. Lonza’s endotoxin detection products are used to perform the LAL test, an Endotoxin Detection, Quality Control test on raw, in-process and final release materials. The LAL test helps ensure that human and animal intravenous drugs, vaccines and medical devices are safe for use. Lonza has been providing endotoxin detection products and services since the 1970s, adapting its offerings and services to the needs of customers and to changing technologies. In 2003, Lonza brought to market PyroGene™, an endotoxin detection method that does not rely on the use of horseshoe crab blood as the raw material. In 2009, the FDA approved 510(K) applications that included the PyroGene™ recombinant Factor C Assay as the final release test. In 2012, the USFDA provided a new Guidance for Industry that states, “a firm may use alternative methods if they provide advantages” such as accuracy, precision, selectivity or sensitivity. Validation in required to use this alternative method using USP <1225>, Validation of Compendial Methodologies” to demonstrate that PyroGene™ rFC has better or equivalent results than a compendial method. Lonza is committed to help protect future generations of the horseshoe crab and invites Professionals to subscribe to their quarterly, free QC Testing Solutions e-Newsletter. For each subscription, Lonza donates $1.00 to the Ecological Research & Development group (ERDG), a non-profit wildlife conservation organization whose primary focus is the conservation of the world’s four remaining horseshoe crab species. To learn more about Lonza’s commitment to sustainability, visit www.lonza.com/hsc.

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