Parallel Session 6B: The Critical Need to Protect the Horseshoe Crab: Initiatives from Industry, Suppliers and Regulators to Replace the LAL Assay

The pharmaceutical industry is increasingly viewed as a key sector systemically important in reversing nature loss.     One of the sector’s key dependencies is on the horseshoe crab , a species that is vital to marine ecosystems only located in a few locations globally.  In 2023, the Pharmaceutical Supply Chain Initiative (PSCI) published a shared commitment that only the US based species will be used because of the critical status of those in Asia .  Populations are declining due to various complex factors with the exploitation for our sector’s use playing a significant role .  The decline of horseshoe crabs also adversely impacts other species within the ecosystems, including the Red Knot, a critically endangered bird which feeds on their eggs in the Delaware Bay.  Increasing calls to protect the horseshoe crabs to halt and reverse this loss poses a significant risk for supply continuity and ultimately for our patients  - The crab’s blue blood contains coagulation factors critical for use in the Limulus Amebocyte Lysate (LAL) assay, which is widely used for detecting bacterial endotoxins as a release assay to ensure safety of pharmaceutical and vaccine products.  

This session will explore the urgent need for regulators, suppliers, and industry leaders to collaborate in replacing the LAL assay with  in vitro alternatives, such as recombinant Factor C (rFC). Experts will discuss case studies that share the ecological impact of current practices, advancements in alternative assays, and the regulatory frameworks needed to facilitate the transition to a new release assay for supply chains to ensure endotoxin free products. Attendees will gain insights into how a united collaborative effort can ensure the preservation of horseshoe crabs while maintaining the safety and efficacy of medical release testing.

Session Speakers:

Sarah Argoud, AstraZeneca

What Do Birds Have to Do with Crabs Have to Do with People?

Holly Bamford, National Fish and Wildlife Foundation

Initiatives from Industry: An Update from the PSCI Horseshoe Crab Blood Working Group

Phil Duncanson, AstraZeneca

Bacterial Endotoxin Testing: Progressive Science and Sustainability

Jay Bolden, Eli Lily and Company