Abstract

Horseshoe crabs have been integral to the safe production of vaccines and injectable medications for the past 40 years. The bleeding of live horseshoe crabs, a process that leaves thousands dead annually, is an ecologically unsustainable practice for all four species of horseshoe crab and the shorebirds that rely on their eggs as a primary food source during spring migration. Populations of both horseshoe crabs and shorebirds are in decline. This study confirms the efficacy of recombinant Factor C (rFC), a synthetic alternative that eliminates the need for animal products in endotoxin detection. Furthermore, our findings confirm that the biomedical industry can achieve a 90% reduction in the use of reagents derived from horseshoe crabs by using the synthetic alternative for the testing of water and other common materials used in the manufacturing process. This represents an extraordinary opportunity for the biomedical and pharmaceutical industries to significantly contribute to the conservation of horseshoe crabs and the birds that depend on them.

Highlights

  • The 450 million-year-old horseshoe crab has been integral to the safe manufacturing of vaccines, injectable medications, and certain medical devices

  • Our findings confirm that the biomedical industry can achieve a 90% reduction in the use of reagents derived from horseshoe crabs by using the synthetic alternative for the testing of water and other common materials used in the manufacturing process

  • Grallert and colleagues found that recombinant Factor C (rFC) overcame other sources of unreliable results that occur during Limulus amebocyte lysate (LAL) testing, including inhibitory constituents of the sample; fewer invalid results, which necessitate retesting; less interference in complex samples; and a broad dynamic range of 0.05 endotoxin units per milliliter (EU/ml) to 500 EU/ml [29]

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Summary

OPEN ACCESS

The bleeding of live horseshoe crabs, a process that leaves thousands dead annually, is an ecologically unsustainable practice for all four species of horseshoe crab and the shorebirds that rely on their eggs as a primary food source during spring migration. Our findings confirm that the biomedical industry can achieve a 90% reduction in the use of reagents derived from horseshoe crabs by using the synthetic alternative for the testing of water and other common materials used in the manufacturing process. This represents an extraordinary opportunity for the biomedical and pharmaceutical industries to significantly contribute to the conservation of horseshoe crabs and the birds that depend on them

Introduction
Importance of the horseshoe crab to the pharmaceutical industry
Ecological impact of biomedical bleeding
Characterization of the LAL test derived from horseshoe crabs
The development of a synthetic alternative
Resolving questions about efficacy of the synthetic alternative
Range of applicability
BioPhorum Operations Group study
Removing barriers to the adoption of rFC
Horseshoe crabs are essential to a healthy ecosystem
Findings
Conclusion
Full Text
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