FDA Approves First Drug Using the Recombinant Factor C Assay for Endotoxin Testing

Posted Nov 08, 2018

Walkersville, MD (USA) / Basel (CH), 8 November 2018 – Lonza announced today 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.”

More information about Lonza’s PyroGene™ Recombinant Factor C Assay is available on the Lonza website:

About Lonza
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. As an integrated solutions provider, Lonza is boosting its value creation along and beyond the healthcare continuum with a strong focus on patient healthcare, consumer preventive healthcare and consumer's healthy environment. Lonza harnesses science and technology to create products that support safer and healthier living and that enhance the overall quality of life. With the recent Capsugel acquisition, Lonza now offers products and services from the custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms for the pharma and consumer health and nutrition industries. 

Benefiting from its regulatory expertise, Lonza is able to transfer its know-how from pharma to hygiene and fast-moving consumer goods all the way to coatings and composites and the preservation and protection of agricultural goods and other natural resources. 

Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 14,500 full-time employees worldwide. The company generated sales of CHF 5.1 billion in 2017 with a CORE EBITDA of CHF 1.3 billion. Further information can be found at

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