FDA Approves First Drug Using the Recombinant Factor C Assay for Endotoxin Testing
9 Nov 2018
Lonza has announced that the 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. Food and Drug Administration (FDA) to have been released using this method instead of traditional Limulus Amebocyte Lysate (LAL) - based methods. Emgality™ is a monoclonal antibody drug treatment 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. 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."
Allen Burgenson, Lonza’s Global Subject Matter Expert for Endotoxin Testing Solutions, said, "Lonza is the commercial innovator in bringing recombinant technology for endotoxin testing to market. This milestone accomplishment in advancing rFC technology will help to ensure the sustainability of the world’s horseshoe crab species. The three species of horseshoe crab found in Asia (Carcinoscorpius rotundicauda, Tachypleus tridentatus and Tachypleus gigas) are in serious decline due to overfishing, habitat loss and their use as a regional food. As these species become depleted due to a lack of regulatory oversight, countries such as China that use them to prepare Tachypleus Amebocyte Lysate (TAL) will look to the North American species, Limulus polyphemus, to fulfill their ever increasing needs in order to release non-pyrogenic pharmaceutical products to the market. Use of recombinant products, such as recombinant Factor C for endotoxin detection will greatly reduce the pressure on these species."