The Atlanta Journal-Constitution
Clean needles depend on blue blood of horseshoe crabs
Niche industry an unknown part of injection chain.
CHARLESTON, S.C. — It’s one of the stranger, lesser-known aspects of U.S. health care — the striking, milky-blue blood of horseshoe crabs is a critical component of tests to ensure injectable medications such as coronavirus vaccines aren’t contaminated.
To obtain it, harvesters bring many thousands of the creatures to laboratories to be bled each year, and then return them to the sea — a practice that has drawn criticism from conservationists because some don’t survive the process.
The blood, which is blue due to its copper content, is coveted for proteins used to create the LAL test, a process used to screen medical products for bacteria. Synthetic alternatives aren’t widely accepted by the health care industry and haven’t been approved federally, leaving the crabs as the only domestic source of this key ingredient.
Many of these crabs are harvested along the coast of South Carolina, where Gov. Henry Mcmaster promoted the niche industry as key to the development of a domestic medical supply chain, while also noting that environmental concerns should be explored.
“We don’t want to have to depend on foreign countries for a lot of reasons, including national security, so it’s good to see this company thriving in the United States,” Mcmaster said. “We want to do everything we can to onshore all of these critical operations.”
One company at forefront
Their biomedical use has been on the rise, with 64,482 crabs brought to biomedical facilities in 2018, according to the Atlantic States Marine Fisheries Commission.
In South Carolina, that’s done only by Charles River, a Massachusetts-based company that tests 55% of the world’s injectables and medical devices — such as IV bags, dialysis solutions and even surgical cleaning wipes, according to company officials.
“We are almost the last line of defense before these drugs leave the manufacturing area and make it to a patient,” senior vice president Foster Jordan told Mcmaster. “If it touches your blood, it’s been tested by LAL. And, more than likely, it’s been tested by us.”
Charles River employs local fishermen to harvest the crabs by hand, a process governed by wildlife officials that can only happen during a small annual window, when the creatures come ashore to spawn.
Contractors bring them to the company’s bleeding facilities, then return them to the waters from which they came. During a year, Jordan said his harvesters can bring in 100,000 to 150,000 horseshoe crabs, and still can’t satisfy the growing demand.
“We need more, though,” Jordan told Mcmaster, adding that his company is working with the state to open up more harvesting areas. “The population’s steady. ... We need access to more beaches, to get more crabs.”
What critics say
The practice is not without its critics, some of whom have argued that bleeding the crabs and hauling them back and forth is harmful. According to the National Oceanic and Atmospheric Administration, 10% to 15% of harvested crabs die during the process.
The International Union for Conservation of Nature listed the species overall as “vulnerable,” noting decreasing numbers as of a 2016 assessment. The Atlantic States Marine Fisheries Commission listed 2019 stock as “good” in the Southeast, but “poor” in areas around New York.
Conservationists sued last year, accusing the U.S. Fish and Wildlife Service of shirking its duty to protect areas including South Carolina’s Cape Romain National Wildlife Refuge by allowing horseshoe crab harvesting. They argued that taking out the crabs affects other species in the protected area. A federal judge temporarily halted the harvest but was reversed following Charles River’s appeal.
Issues with alternatives
There is a synthetic alternative to the horseshoe crab blood, but it hasn’t been widely accepted in the U.S. Meanwhile, Charles River’s international competitors are making synthetics and also pressing for U.S. Food and Drug Administration approval, which Jordan said could hamper domestic efforts like his own.
“My mission is to make sure that any competitor that comes into the United States, from China or any of these other producers, has to go through the same regulatory process that we had to go through, to make sure that it’s safe,” Jordan said. “If all these synthetics start coming in from other countries, we’re going to lose the protection that we’ve had for all these years, and the safety, and the control of the drug supply.”