Behind every implantable medical device, injectable pharmaceutical, or vaccine is the Atlantic horseshoe crab and the aqueous extract of its blood cells (amebocytes), Limulus amebocyte lysate (LAL). Comprised of proteins, LAL is used to detect the presence of endotoxins. In the 50 years since this discovery, the blood of the horseshoe crab has served as a natural indicator of bacterial contamination in critical medical treatments all over the world. 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, expensive, and rabbits perished unnecessarily. By contrast, the blood of the horseshoe crab is carefully collected through a controlled breeding program and hand-collection process that allows them to be returned to the ocean the same day.
Charles River Laboratories is one of, if not the biggest, supporter of this lifesaving creature and strives to make efforts to ensure its protection. In 1992, Dr. James Cooper, a pioneer in the research and development of the LAL assay, and his wife Frances wrote draft legislation that promoted the conservation and regulation of horseshoe crab fisheries. As a result, the South Carolina state legislature enacted laws to protect the indigenous Atlantic horseshoe crab population. A framework was created to ensure the protection of the horseshoe crab based on the need for educational and biomedical purposes, eliminating the ability to harvest for bait. Now, with the addition of six island sanctuaries, the horseshoe crabs in South Carolina are one of the most protected species on the East Coast of the United States. Currently, the population continues to remain stable where biomedical testing is present in the Northeast and thrive and grow in the Southeast.
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 and would again fall prey to use as bait by fishermen. To ensure pharmaceutical organizations can continue to remain compliant and safe with their required testing procedures while still providing horseshoe crabs the advantage of biomedical protections, Charles River has developed to be the most environmentally friendly, patient-safety focused FDA-licensed endotoxin testing method available. Endosafe® cartridges use significantly less raw material, just 5% compared to traditional methods.
At Charles River, we are committed to the conservation of this extraordinary species that contributes to the everyday health and safety of people all over the world. To learn more about how we are helping ensure the continued population growth of the horseshoe crab, please visit hsc.criver.com.