New Study Proves Synthetic Can Replace Horseshoe Crab Blood in Biomedical Testing
CAPE MAY, N.J., May 10, 2018 /PRNewswire/ — Revive & Restore, a California-based nonprofit bringing new biotech tools to conservation, today joined with First Lady Tammy Murphy, New Jersey Audubon, and Eli Lilly and Company to announce new research that dispels many perceived barriers to the adoption of a safe synthetic alternative to horseshoe crab blood for biomedical testing.
Over the past 40 years, the population of American horseshoe crabs, an ancient and ecologically important species, has declined, because of the overharvest of crabs and extensive use in biomedical testing.
“Both people and nature will win through the leadership of Eli Lilly to replace the need for harvesting horseshoe crabs for biomedical use,” said First Lady Tammy Murphy.
“The annual convergence of the horseshoe crab and the Red Knot along the Cape May shore shows both the important role New Jersey plays in maintaining nature’s delicate balance, and the important role corporate actors can play in ensuring a sustainable and healthy horseshoe crab population,” she said.
“It is a treat to witness the Red Knot’s stop-off along the shores of the Delaware Bay during their remarkable 10,000-mile migration, and through the efforts of Eli Lilly, this is an annual event we can ensure continues for generations to come,” The First Lady added.
Ryan Phelan, executive director of Revive & Restore, said, “When we learned there was an alternative to bleeding hundreds of thousands of horseshoe crabs annually, which was not being used, we felt compelled to find out why and to remove any barriers to adoption.”
Eric Stiles, president & CEO of New Jersey Audubon, explained the new research can be a substantial benefit to the Red Knot, an endangered shorebird that relies on horseshoe crab eggs in the Delaware Bay to refuel before they continue their journey to raise their young in the Arctic.
“Research has shown that nearly 30 percent of horseshoe crabs die because of this ongoing blood harvest,” Stiles said. “This greatly impacts the Red Knot, an endangered shorebird, who need to feast on horseshoe crabs to fuel their journey to Arctic breeding grounds. We welcome this research and appreciate the leadership support of First Lady Murphy and Eli Lilly and Company. We invite other pharmaceutical companies to join us in saving shorebirds, horseshoe crabs and advancing the interest of their shareholders.”
Revive & Restore conducted a review and synthesis of 10 separate studies that evaluated the industry’s standard method of testing for bacterial contaminants, the horseshoe crab blood-derived LAL test, against the synthetic alternative, recombinant Factor C (rFC).
The paper, “Saving the Horseshoe Crab: A synthetic alternative to horseshoe crab blood for endotoxin detection,” was published today in PeerJ. Revive & Restore examined the methods and data from 10 prior efficacy studies. Consistency of results, reliability of the method, and scope of efficacy were all reviewed.
Eli Lilly and Company announced that it has updated its processes to use rFC for testing water in laboratories at two of its manufacturing sites.
“Lilly is a leader in the sustainable production of therapeutics, and we believe that rFC provides a much more sustainable testing process,” said Jay Bolden, a senior scientist with Lilly.
Details were released at New Jersey Audubon’s Cape May Center for Research and Education. Below are the highlights:
- The review confirmed that rFC is just as efficacious, safe, and reliable as the product made from the blood of horseshoe crabs.
- According to interviews with industry experts, substituting LAL with the synthetically-produced rFC for testing water and other common materials used in manufacturing could reduce the use of horseshoe crab blood by 90 percent.
- rFC causes fewer false positives and is cost-effective. rFC is also becoming more widely available since patent protections have expired. The use of rFC for testing in the production process of injectable medications is currently allowed under the U.S. Food & Drug Administration’s guidelines.
Bacterial endotoxins can cause life-threatening fever and toxic shock. Vaccines and injectable medications approved by the U.S. Food & Drug Administration must be tested for bacterial contamination. Since the late 1970s, the horseshoe crab has been essential to the safe manufacturing of injectable medications, including vaccines, because a unique clotting protein in its blood is extremely sensitive to bacterial contamination.
Revive & Restore’s research confirmed that the efficacy of rFC is equivalent to LAL and, because patent protections have ended, more suppliers are expected to start manufacturing rFC. Despite being commercially available since 2003, the adoption of rFC has lagged until now.
“Demand for the horseshoe crabs by the bait and biomedical industries over the last three decades has caused significant ecosystem-level impacts,” said David Mizrahi, Vice President of Research and Monitoring, New Jersey Audubon. “Six species of long distance migrant shorebirds synchronize their northward migration to Arctic nesting grounds so they arrive in Delaware Bay to gorge on the eggs of spawning horseshoe crabs.
“Recent studies confirm that abundant horseshoe crab populations in Delaware Bay are critically important for the successful migration and breeding of these six species and their long-term conservation,” he added.
“Today we have the opportunity to turn the tide,” Phelan said. “Transitioning away from the bleeding of the horseshoe crabs to a readily available synthetic alternative is a win-win situation—for the crabs, the birds, and people—by ensuring the safe and sustainable manufacturing of pharmaceuticals while sparing the crabs and the birds that depend on them.”
Tweet: Published today, @Revive_Restore’s review of 10 studies demonstrating the efficacy of a synthetic alternative provides a path forward for #pharma to end its dependence on the #horseshoecrab