The biomedical industry’s need for the horseshoe crab has, in fact, driven the development of laws to protect the animal.
Their best security is the biomedical industry’s continued reliance on them. Without the need for LAL, the legal protection for the horseshoe crab is not guaranteed, and they would again fall prey to overfishing and use as bait for eel and whelk. For this reason, it is critical that we serve as advocates for the humane treatment of these animals, and strive to achieve balance between our need for this valuable material and the livelihood of the animal that provides it. Thanks to its use in biomedical research, the horseshoe crab maintains its protective status, allowing the population to continue to flourish.
As keepers of the environment, we have a responsibility to preserve, protect and live harmoniously with the animals that share our planet. As a source of critical proteins that detect the presence of endotoxins in products and instruments used by humans, the Atlantic horseshoe crab has long been treasured by the biopharmaceutical industry.
For this reason, it is critical that we serve as advocates for the humane treatment of these animals, and strive to achieve balance between our need for this valuable material and the livelihood of the animal that provides it. Charles River is proud to play a role in alleviating pressures on horseshoe crab populations through tireless conservation efforts, active animal welfare campaigns and decades of research and development.
Limulus polyphemus, known as the Atlantic horseshoe crab, is an ancient mariner with
a lineage that dates back
Though they look similar to crustaceans, they actually belong to the subphylum Chelicerata, relating them more closely to spiders and scorpions. Limulus polyphemus is found along the Atlantic and Gulf coasts from northern Maine to the Yucatán Peninsula, with the Delaware Bay as the center of the population. This interesting animal is important, not only for the pivotal role it plays in its ecosystems, but also for its valuable contribution to biomedical research applications.
The true beauty of this remarkable creature, however, is seen in its primitive immune system. Instead of developing antibodies in response to infection, the immune system releases proteins that can bind and kill bacteria. In addition, other immune proteins clot when exposed to waterborne bacteria, a mechanism which forms the basis of the LAL test.
Limulus amebocyte lysate (LAL) is an aqueous extract of blood cells (amebocytes) from the horseshoe crab. Comprised of proteins, LAL is used to detect the presence of endotoxins. In the
50 years since this discovery, horseshoe crab blood has served as a natural indicator of bacterial contamination in critical medical treatments all over the world. So why is endotoxin detection so important? Endotoxins are a cell wall component of gram-negative bacteria that cause a pyrogenic response (fever). They are extremely potent, heat stable, and present everywhere bacteria are or have been. With its specificity, simplicity and remarkable sensitivity, LAL, which is derived from horseshoe crab blood, ensures the safety of products such as intravenous drugs, vaccines and medical devices.
Learn more about our LAL products. >>
Prior to FDA approval of LAL in the 1980s, the rabbit pyrogen test was the standard FDA-approved test for endotoxins. This test, however, was labor intensive, lengthy and expensive. Years of research and application have proven LAL to be unequivocally recognized as the most sensitive method available for the detection of endotoxins. To illustrate, LAL can detect as little as 1 pg/mL of harmful bacterial endotoxin (equivalent to one grain of sand in an Olympic-sized pool).Approximately 70 million LAL tests are performed each year, and there have been no FDA-confirmed pyrogenic outbreaks due to the failure of LAL detecting the presence of endotoxin. As a highly regulated product, manufactured LAL undergoes biannual inspections by the FDA and must conform to cGMP requirements. Of course, to manufacture LAL, horseshoe crab blood must be carefully collected through a controlled bleeding program. Policies such as hand-harvesting and same-day return to the sea ensure the animals’ safety. With a focus on innovation, humane care and environmental protection, Charles River has responsibly manufactured LAL since 1987.
Learn more about our rapid endotoxin products. >>
Charles River has been a pioneer in the realm of endotoxin detection, developing an FDA-licensed LAL cartridge that further safeguards the 440-million-year-old species by using 20 times less raw material than traditional LAL tests. If all tests were performed using this optimized technology, today’s entire worldwide demand could be met with the horseshoe crab blood collected from our current annual quota of animals.Our cartridge technology is the most environmentally conscious strategy because it significantly reduces the amount of LAL per test and minimizes the need for retesting that is often necessary with traditional methods.
Learn more about our FDA-licensed cartridge technology. >>
In 2006, Charles River launched the Endosafe®-PTS™, the first portable endotoxin test system that accelerates the discovery and development of new drugs by detecting endotoxin contaminants in drugs, medical devices and biological products. Recently, the PTS™ arrived aboard the International Space Station, where astronauts began using the system to perform biological studies necessary for an extended human presence in space–from crew health and spacecraft environmental studies to the search for life elsewhere in the solar system. NASA recently used the Endosafe®-PTS™ to monitor the environment for microbial contamination during the construction of the Mars exploration rovers "Spirit" and "Opportunity". Future applications of PTS may include monitoring the spread of Earth-derived biological material to the Moon and detecting signs of microbial life on Mars.
Learn more about our adventures in space. >>
We are committed to employing only fishermen licensed by the Department of Natural Resources to hand-harvest horseshoe crabs from the coastal waters of South Carolina. Our highly controlled and monitored procedures enable us to collect enough raw material for 24 months of LAL production from a minimum number of donor animals. Once the crabs are brought into our lab, they are carefully inspected by trained employees who determine the animal’s health and maturity. After careful collection of a measured amount of horseshoe crab blood, the crabs are returned unharmed to their natural habitat within the same day, and their blood volume rebounds quickly. These practices have allowed Charles River to achieve an industry-leading survival rate of donor animals.
Much of the continued survival of the horseshoe crab can be attributed to its inherent adaptability, as well as modern-day government protection. Prior to 1991, there were no laws or regulations in South Carolina dealing with horse shoe crabs. Increased fishing industry demands Limulus Polyphemus made it necessary to develop a state-wide management plan to conserve this resource. In 1992, Dr. James Cooper (a pioneer in the research and development of the LAL assay) wrote draft legislation that called for the management and regulation of horseshoe crab fisheries.1 As a result, the South Carolina state legislature enacted laws to protect the indigenous horseshoe crab population. In South Carolina, horseshoe crabs must be harvested by hand and only be used for biomedical applications (LAL production) and marine biological research, not as bait for the eel and whelk industries. The addition of six island sanctuaries makes the horseshoe crabs in South Carolina one of the most protected species on the East Coast of the United States.
We are committed to employing only fishermen licensed by the Department of Natural Resources to hand-harvest (as opposed to trawling) horseshoe crabs from the coastal waters of South Carolina. Our highly controlled and monitored procedures enable us to collect enough raw material for 24 months of LAL production from a minimum number of donor animals. Today, the horseshoe crab’s blood is still the most sensitive, accurate and reliable detector of dangerous bacteria found in anything from flu vaccines to outer space.
Once the crabs are brought into our lab, they are carefully inspected by trained employees who determine
the animal’s health and maturity. At the facility, crabs are cleaned, inspected and prepped for bleeding. About
25% of the crab’s blood is removed in the collection of their blood cells, or amebocytes, which are similar to
After careful collection of a measured amount of blood, the crabs are returned unharmed to their natural habitat within the same day, and their blood volume rebounds quickly.
In 2019, the Atlantic States Marine Fisheries Commission (ASMFC) Stock Assessments emphasized that the horseshoe crab population in the Southeastern Atlantic coast has remained in good standing for the last several years.2 Additionally, the Southeast Area Monitoring & Assessment Program (SEAMAP) Coastal Trawl Survey, conducted by the South Carolina Department of Natural Resources, shows a population increase over the last several years.3 Results from a South Carolina tagging study also demonstrated that bled horseshoe crabs are able to return to spawning beaches in subsequent years.
1. SC Code 50-5-1330 (2012). http://law.justia.com/codes/south-carolina/2012/title-50/chapter-5/section-50-5-1330/
2. Atlantic States Marine Fisheries Commission Stock Assessments. http://www.asmfc.org/uploads/file/5cd5d6F1HSCassessment_PeerReviewReport_May2019.pdf.
3. South Carolina Department of Natural Resources, Marine Resources Research Institute,
"Southeast Area Monitoring and Assessment Program: South Atlantic"
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The biomedical industry and ongoing conservation efforts continue to be a positive attributing factor to horseshoe crab sustainability.
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Marine scientists document LAL industry's conservation of the horseshoe crab.
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Living Fossils and Blue Blood: The Story of the Horseshoe Crab and Human Health.
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Biomedical manufacturers and conservationists alike have a vested interest in making sure these invertebrates continue to thrive and flourish. Find out how the species is faring.Read More
Eureka guest blogger, Jerry Gault, a longtime South Carolina fisherman, talks about his moral duty and legal responsibility to handle horseshoe crabs with care.Read More
John Dubczak talks about the importance of endotoxin testing in drug development.
At night, during the full and new moon in late May and early June, the sands of East Coast beaches host a dance that is a half-billion years old.Read More
Learn about the horseshoe crabs’ remarkable story of survival and adaptability.
Horseshoe crabs live in the ocean year-round, but they make one annual visit to the shoreline to lay eggs in sandy, wet beaches.Watch the Video
The Atlantic horseshoe crab has found allies in the biotech community. Find out why.
For more information about our commitment to the
Atlantic horseshoe crab or to request a copy of our conservation poster or brochure.