STAT Plus: Despite protest, industry group backs use of horseshoe crab blood to test for bacteria in drugs
After a lengthy review, the organization that sets manufacturing standards for drug makers will keep a decades-old test — derived from horseshoe crabs — as its go-to tool for detecting contamination in medicines and vaccines, rather than recommending that drug makers switch to a synthetic alternative test.
The decision centers around endotoxin tests, which are used to detect bacterial contamination in intravenous drugs and vaccines, among other products. But controversy over the ongoing supply of horseshoe crabs — whose blood is used for reagents — and a battle between two of the biggest test suppliers prompted the U.S. Pharmacopeia to review its manufacturing standards for drug makers.
