Environmentalists, as well as a major European investor, are putting pressure on pharmaceuticals companies to find alternatives to using the blood of horseshoe crayfish to test medical devices and vaccines.
Blood is used in millions of tests every year to detect endotoxins – poisons that are found inside bacteria cells and can cause illness. The pressure on pharmaceutical companies to switch over to synthetic substances is increasing as the populations of horseshoe crabs, seabirds who eat their eggs and other creatures are declining.
The asset management division BNPParibas of the French banking group has written to 14 of the largest pharmaceutical companies in the world, asking them to substitute blood from horseshoe crayfish for a substance called recombinant Factor C (rFC).
Adam Kanzer is the head of Americas Stewardship for BNP Paribas, a company that manages €526bn.
Horseshoe crabs are more closely related to spiders and crabs than they are to crabs. They have been living in the oceans since 450 million years ago, long before dinosaurs roamed our planet. Their numbers are decreasing due to habitat destruction and the increased collection of biomedical and fishing industries. The International Union for Conservation of Nature has listed the tri-spined horseshoe crab as endangered. The American horseshoe Crab is listed as “vulnerable” by the global environmental protection organization.
The US allows the biomedical sector to take a small amount of horseshoe crab blood, and then release the animal alive back into the same area. According to US authorities in 2021, almost 720,000 horseshoes crabs were harvested and their blood extracted. Of these, it is estimated that approximately 112,104 died.
Environmentalists have made horseshoe crabs a priority. Earthjustice, a group of environmental lawyers, listed it as a priority lobbying issue in the US Senate disclosure files last year. Before BNP became involved, protecting them was not on the list for investors interested in environmental, social, and governance issues.
In May, the Pharmaceutical Supply Chain Initiative (PSCI), a lobby group set up by major pharmaceutical companies , said that its members must stop sourcing blood of the two Asian species of horseshoe crabs most at risk. The London-based PSCI warned that continuing to harvest horseshoes crabs for their blood could lead to a population decline. It encouraged its member companies to “explore and adopt alternative methods”.
Eli Lilly in Indianapolis has converted 80 percent of its endotoxin test capacity to rFC. Regulators have approved eight products using these tests. Pfizer, Roche and other drug companies are piloting the use of rFC in some of their facilities.
Jay Bolden is a Lilly biologist who said that the company started to switch to rFC because of concerns over possible “pinches” in the supply chain when US authorities declared the red knot seabird endangered in 2015. The red knot, a seabird, was declared endangered by US authorities in 2015.
There are many regulatory obstacles that make it hard to change completely. Bolden, a bird-watching enthusiast, said that they are working to change this.
Lonza, a Swiss biosciences firm that has developed a new alternative test, says the lack of standards for the use of rFC is one reason why synthetic tests are not more widely used. Lonza stated that US Pharmacopeia, a non profit organisation which sets standards for US-made medicines, hasn’t published any rFC standards.
USP terminated members of the rFC committee last year, citing their inability to “work collaboratively and productively” which impeded the standard-setting process.
USP released a statement after this article first appeared on Tuesday. The statement proposed a set of new standards for the use of synthetic alternatives to horseshoe-blood. USP expressed its hope that the standards would be implemented in next year’s after a period of consultation.
Jaap Venema is the chief scientist at USP. He said that the proposed standards will provide “regulatory clarity” to manufacturers who have switched from synthetics, and reduce the amount of testing needed for new products.
He said, “We hope that it will encourage the shift because we’ve had for a very long time as one of our top priorities to use less animals for testing reagents.”