LAL is saving the Atlantic Horseshoe Crab
Thanks to its use in biomedical research, the horseshoe crab maintains its protective status allowing the population to continue to flourish. Without the continued need by the biomedical industry, the legal protection for this special species is not guaranteed, and horseshoe crabs would again fall prey to use as bait by fisherman.
To dispel the myths currently being disseminated within the biomedical industry about the population status of the Atlantic horseshoe crab and the use of its blood in the testing process, here are some key facts and scientific data to clear up any confusion and educate those who might be concerned about the horseshoe crab.
With the emergence of COVID-19, there are not enough Atlantic horseshoe crabs to provide the global LAL demands.
Fact: Our FDA-licensed LAL test cartridges (license # 1197) use less than 95% of the raw material required for a traditional bacterial endotoxin test. If all LAL tests were performed using this optimized technology, today’s entire worldwide LAL demand could be met with the blood from less than our current annual quota.
Recombinant LAL technologies are more sustainable and protect the Atlantic horseshoe crab.
Fact: The blood of the horseshoe crab is a natural, sustainable resource that is treasured by the biomedical industry, making the donor animal the focus of protection and conservation efforts. Without the continued need by the biomedical industry, the legal protection for this species is not guaranteed. The synthetic alternative to horseshoe crab blood is not FDA-licensed for end-product release, is not controlled by the same strict quality requirements as LAL, and requires time and funding to validate its use.
Biomedical companies kill Atlantic horseshoe crabs for their blood.
Fact: Crabs gathered for Charles River’s strictly controlled bleeding program are hand collected by licensed fishermen and carefully returned, unharmed, to their natural habitat the same day. Charles River treats the Atlantic horseshoe crab with the utmost care and respect during the collection process. We employ only the most careful procedures when handling horseshoe crabs, whose continued success as a species is important both to biomedicine and the local ecosystem.
The Atlantic horseshoe crab bleeding process is a big secret.
Fact: LAL manufacturers are required to provide detailed information on the number of animals bled, delivered, their sex, types of injuries, and mortalities, if any, to the Department of Natural Resources. This information is then made public on the website of the Atlantic States Marine Fisheries Commission.
There isn’t enough LAL supply to meet the expended demand of COVID-19 therapies.
Fact: There are approximately 70 million LAL tests performed globally. All three LAL manufacturers have estimated that to make the anticipated five billion doses of the COVID-19 vaccine, 600,000 LAL tests will need to be performed, which will use the amount of lysate created in a single day, placing no undue burden on the lysate supply chain or the American horseshoe crab population.1
The Atlantic horseshoe crab is an endangered species.
Fact: While the IUCN Red List considers Limulus polyphemus a vulnerable species, the most recent stock assessment report published by the Atlantic States Marine Fisheries Commission highlights the progression over the past 10 years of the regional stock benchmarks and current status. Atlantic horseshoe crab populations have increased in the southeast, and in all areas where the biomedical industry is present the populations are either stable or thriving.
The blood of the Atlantic horseshoe crab is unnecessary for life-saving medications.
Fact: Most, if not all, life-saving drugs require compendial bacterial endotoxin testing before they are released. The current FDA-approved LAL test derived from the blood of the horseshoe crab plays a critical role in ensuring the safety of these products and, more critically, the safety of the patient receiving the product.
The biomedical industry is responsible for the declining population of the Atlantic horseshoe crab.
Fact: The commercial baiting industry is the largest threat to the Atlantic horseshoe crab, while the biomedical industry’s need for them has actually driven the development of laws to protect it. Without these laws they would fall prey to overfishing. The 2019 Horseshoe Crab Benchmark Stock Assessment Peer Review Report highlights that in 2016, 787,223 horseshoe crabs were harvested in permitted states along the Atlantic coast for eel and whelk bait, resulting in a 100% mortality rate.
Fact: In 2000, the Atlantic States Marine Fisheries Commission introduced trawling quotas to limit the number of horseshoe crabs caught for uses other than LAL, reducing collection numbers by 80 percent.
There are no restrictions on how many Atlantic horseshoe crabs can be caught.