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.
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 standards.
For more than a year, the organization had been evaluating whether to fully incorporate a synthetic alternative known as recombinant factor, or rCF, into its compendium, or standards book. Companies that use this approach have to perform additional work to validate their test results before submitting marketing applications to the Food and Drug Administration.
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