New Jersey and Pharma: The Horseshoe Crab Link

Everyday I learn something new about clinical trials, as well as the pharmaceutical industry in general. For example, did you know that the blood of horseshoe crabs are used to detect bacteria in manufactured pharmaceutical products?

Apparently, horseshoe crabs have copper-rich blood, which also contains amoebocytes that coagulate around the wound of a horseshoe crab that forms a “viscous gel surrounding the invading bacteria.”

This was discovered in 1956 and led to the commercial use and process for horseshoe crabs’ blood into a detector for bacteria contamination in drugs, vaccines and medical devices. All of these are manufactured carefully for sterility, but the LAL test from which the crabs’ blood is derived, can detect bacterial components that have survived that process.

This is a fine use of horseshoe crabs. Even the article from which I referenced the above information describes how, in some instances, 30% of a horseshoe crab’s blood is removed and then the crab is allowed to go free and alive. This would be unlike the crabs that get captured off the Atlantic Coast in the United States, who are killed and used for bait, which to me is not a fine use of horseshoe crabs. The population of horseshoe crabs is in decline and their demise is causing an equal demise to the red knot birds, who stop and feed off horseshoe crab eggs in the Delaware Bay before continuing their 9,000 miles round-trip migration from the south of South America to the Canadian Arctic.

This complex relationship between red knot and horseshoe crab and pharmaceutical industry is detailed in thisNew York Times article.

As a child going to the Jersey Shore, I was not a fan of horseshoe crabs--they would hit your legs in the surf or just look generally prehistoric and menacing. But as I got older, I learned to miss them and noticed that there were fewer. Now I know why. Bait. Seeing one on the beach these days is enough to get me out of my chair, grab the kids and go running down the beach to look at them. But little did I know that they are a major food source for the birds, as well as a real trooper in the drug development chain.

So I hope by pointing out the horseshoe crab dilemma doesn’t provoke people who grind axes against pharmaceutical companies. (Alert: the article reference on LAL describes how synthetic LAL is in development). Pharmaceutical companies have a lot on their plate right now developing new R&D relationships, and handling regulatory issues. And to add more to the regulatory burden of pharmaceutical companies, how’s this….from the New York Times article, the Atlantic States Marine Fisheries Commission monitors the use of the crabs by the biomedical industry, and is considering limits on them. Which person in a pharma’s regulatory affairs department gets that job?