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Case Studies

Leading the Industry in Ecologically Sound Endotoxin Testing

Lilly continues to be an industry leader in using rFC, a scientifically proven, sustainable alternative to the horseshoe crab-sourced testing reagent, LAL. Both tests seek out the presence of harmful bacterial toxins in the injectable medicine manufacturing process.   

Multiple peer-reviewed studies that have evaluated and established comparability of rFC and LAL, using both standard and environmental endotoxins. This is especially important now given that several species of crabs are under threat or endangered from habitat loss and overharvesting, which negatively affects the ecosystems inhabited by horseshoe crabs and other species. 

Currently, Lilly has converted 80% of our testing of medicines from LAL to rFC. We began to implement rFC testing in 2016.  Lilly uses rFC in all eight of our injectable manufacturing facilities and for all our new injectable medicines. These medicines have been approved by global health authorities and contribute to the health of millions of people around the world.      

Lilly supports and is pleased to see broader use of rFC in the pharmaceutical industry. This is not new science – rFC is derived from recombinant biotechnology, which Lilly has pioneered since 1982. As more pharmaceutical companies move away from LAL and embrace rFC, the environment and ecosystems in key parts of the world will benefit – all while maintaining patient safety.

External Collaborations and Partnerships

Biodiversity is a broad topic, and it is important to understand where the pharmaceutical sector can make a difference. Lilly is actively involved in working with external partners and industry working groups to assess and prioritize the risks to biodiversity. As we continue to collaborate and identify relevant risks and opportunities associated with the pharmaceutical industry, this will inform and enhance our evolving strategy and implementation plan.

See important information about our ESG report.