The turning tides of endotoxin tests

To test for bacterial toxins in injected drugs , most drugmakers use an assay whose ingredients are harvested from horseshoe crab blood. New regulations due out in November will make it much easier to use animal-free alternatives for products sold in the US. Some of those alternatives have been available for years, but regulators have been cautious about accepting them. The new rules went forward only after the US Pharmacopeia dismissed an expert committee amid years of debate and industry and environmental lobbying. At a recent meeting of the Parenteral Drug Association, where industry microbiologists discussed ways to make drugs without a trace of unwanted biological material, photos of horseshoe crabs danced across a screen between sessions. The sediment-snuffling arthropod with a dozen legs and a shell like a helmet may seem like an unlikely pairing with the sleek, highly engineered robotics of a pharmaceutical production line. But estuaries teeming

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Publication Details

Journal
C&EN Global Enterprise
Published
2024-10-28
DOI
https://doi.org/10.1021/cen-10234-cover1
Primary Topic
Animal testing and alternatives
Type
article
Field-Weighted Citation Impact
0.00
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article

The turning tides of endotoxin tests

Laurel Oldach
C&EN Global Enterprise
Animal testing and alternatives
article

The turning tides of endotoxin tests

Laurel Oldach
article en

Abstract

To test for bacterial toxins in injected drugs , most drugmakers use an assay whose ingredients are harvested from horseshoe crab blood. New regulations due out in November will make it much easier to use animal-free alternatives for products sold in the US. Some of those alternatives have been available for years, but regulators have been cautious about accepting them. The new rules went forward only after the US Pharmacopeia dismissed an expert committee amid years of debate and industry and environmental lobbying. At a recent meeting of the Parenteral Drug Association, where industry microbiologists discussed ways to make drugs without a trace of unwanted biological material, photos of horseshoe crabs danced across a screen between sessions. The sediment-snuffling arthropod with a dozen legs and a shell like a helmet may seem like an unlikely pairing with the sleek, highly engineered robotics of a pharmaceutical production line. But estuaries teeming

C&EN Global EnterpriseVol. 102(34)
Openalex Percentile: Top 77%
Animal testing and alternatives
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