As nature's only source of Limulus amebocyte lysate (LAL), the gold standard for bacterial endotoxin detection, the blue-blooded Atlantic horseshoe crab is critical to the safety of injectable drugs.
Remarkably, just a single day's production of LAL can test the anticipated 5 billion doses of the most coveted COVID-19 vaccine. However, a lot of questions have arisen regarding how pharmaceutical manufacturers are going to keep up with production demands amid a global pandemic.
In 2019, The Atlantic States Marine Fisheries Commission (ASMFC) compiled a comprehensive two-year study on the status of the Atlantic horseshoe crab and how its population was stable and thriving through the Atlantic coastal waters.
Dr. James Cooper, who established the first commercial LAL in 1971, reveals the impact of advocacy for these 445 million-year-old creatures in his blog post, "The LAL Industry's Remarkable Stewardship of Horseshoe Crabs."
Amidst the misinformation from activists out in the field, the FDA has a zero-tolerance policy for endotoxin contamination, so it’s critical to ensure the methodologies and technology we use are up to par. Charles River's senior technical writer Rachel Kerr concurs. Writing for American Pharmaceutical Review, she details the shortcomings found in recombinant endotoxin testing products and the pause we should take to ensure patient safety.
With several vaccines in development, the race to the COVID-19 vaccine finish line is a hot topic, however data-driven decisions and sound science need to remain the foundation of pharmaceutical manufacturing.
Just ask Foster Jordan, Charles River’s CVP for Microbial Solutions. Foster’s only had one job his whole life – working for South Carolina based Endosafe®, the FDA-licensed facility manufactures LAL. Over his long career, Jordan has immersed himself in the science of LAL and conservation of the crabs from which it comes.
Jordan discusses horseshoe crabs, recombinant endotoxin testing technologies, and what's at stake for the pharma industry on Eureka's Sounds of Science podcast, but his contributions and insight can’t be overlooked. He's positive that when a vaccine becomes available, the horseshoe crab will continue to protect patients as it has for nearly 50 years.