Wildlife advocates are pushing drugmakers to curb the use of horseshoe crab blood by switching to a synthetic alternative for safety tests, including those needed before a COVID-19 vaccine can be used on humans.
Fishermen net hundreds of thousands of the creatures off the U.S. East Coast and Asia every year, draining their prized milky-blue blood for use in medical safety tests that detect bacterial contamination in intravenous drugs or implants.
The National Audubon Society, Defenders of Wildlife and other groups called for greater use of a man-made option, called recombinant Factor C (rFC), in a statement released on Monday by umbrella organization the Horseshoe Crab Recovery Coalition.
They say this shift could save 100,000 horseshoe crabs annually on the U.S. East Coast alone and help threatened migratory birds that depend on crab eggs for survival.
“It is unfortunate that biomedical research still relies on the harvesting of a vulnerable wild animal population when there is a simple, effective, sustainable replacement,” said Ryan Phelan, a campaigner with California-based conservation group Revive & Restore.
However, the testing industry’s impact on the U.S. crab population is disputed, with varying estimates of how many die during bleeding or after they are returned to the ocean.
Swiss biotech company Lonza, a leader in the field, said that good stewardship had led to “stable to increasing” populations.
Regulatory hurdles to rFC also remain, with U.S. standards group U.S. Pharmacopeia (USP) last week scrapping plans to put the synthetic test on an equal footing with industry-standard crab blood trials.
While Europe is moving to recognize the synthetic as comparable, USP announced on Friday that more data was needed to support such a move.
Adoption has lagged, in part, because drug regulators have demanded that rFC endotoxin tests undergo extra validations – adding time and cost – to prove they match the accuracy of crab blood.
So far, only two drugs, both from Eli Lily, have been approved after relying on rFC for final endotoxin tests.
Eli Lilly, which has switched 90% of its safety testing to rFC since 2016, on Monday told Reuters that it supports the wildlife groups’ aims to get more companies to follow suit.