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

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 in the horseshoe-crab clotting cascade activated by the presence of endotoxins. According to the company, as an animal-free method, the PyroGene Assay offers a more sustainable alternative to LAL-based tests that use the lysate obtained from horseshoe crab blood as their main ingredient. 

"The recent FDA approval of Emgality marks a significant breakthrough in establishing the recombinant Factor C Assay as the non-animal method of choice for the identification of contaminating endotoxins in drug products," said Lakiya Wimbish, product manager for Lonza’s PyroGene Recombinant Factor C Assay. "This development serves as an official confirmation that the recombinant Factor C method can be as accurate, sensitive and specific as LAL-based methods, while helping to secure the supply of natural resources." 
 

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