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FDA Approves Lilly’s Emgality Using Lonza’s Factor C Assay

Becomes first FDA approved drug using this method instead of traditional LAL

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By: Kristin Brooks

Managing Editor, Contract Pharma

Lonza’s recombinant Factor C (rFC) Assay has been used for endotoxin testing of Eli Lilly’s Emgality (galcanezumab), the first drug approved by the U.S. FDA to have been released using this method instead of traditional Limulus Amebocyte Lysate (LAL). Emgality is a monoclonal antibody drug for the prevention of migraine in adults.  In 2003 Lonza launched the PyroGene recombinant Factor C Assay, the first endotoxin testing method to utilize a recombinant form of Factor C, the first component i...

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