https://www.npr.org/2023/09/23/ [login to see] /vaccines-are-still-tested-with-horseshoe-crab-blood-the-industry-is-finally-chan
Pharmeceutical companies could soon have easier access to synthetic alternatives to horseshoe crab blood, a key ingredient used to test vaccines and medical devices for contamination.
The U.S. Pharmacopeia, the regulatory body in charge of setting national safety standards, announced a proposal on Aug. 22 that would make it simpler for companies to use the alternatives. The new standard, which is expected to take effect in early 2024, is one of several changes enacted since NPR reported in June on the lack of oversight in the horseshoe crab blood harvest on the east coast, including in areas where the crabs' eggs are considered an important food source for rare birds.
The blue blood of the horseshoe crab clots when it comes into contact with bacterial toxins, which helps technicians identify contaminated products. A synthetic alternative to the blood-derived testing ingredient, called limulus amoebocyte lysate, or LAL, was invented decades ago. Alternatives have since become mainstream; most of the east coast bleeding companies now also sell tests made with a synthetic, not just LAL, and the European Pharmacopoeia considered the synthetic ingredient equivalent to the crab-derived one in 2020. But since scientists at the U. S. Pharmacopeia had not yet done the same, drug companies that wanted to use them faced extra regulatory hurdles in the U.S..