The PSCI presents its report on the use of Horseshoe Crab Blood for Endotoxin Testing in the Pharmaceutical Industry. The report provides insights into the context and complexities behind its use, pathways for better practices in the industry, an insight into the PSCI member companies’ use and next steps both the PSCI and others working in this ecosystem can take going forward.

The PSCI have been engaged on the topic of Horseshoe Crab Blood since 2023. Following the development of its position paper and convening through the working group. The PSCI has been discussing and exploring better pathways for better practices in the pharmaceutical industry and this report encouraging companies to minimize its use and seek alternatives for endotoxin testing in their supply chains.

Pharmaceutical companies use horseshoe crab blood to test medicines and vaccines for safety. The blood is a bright blue colour and has a special quality that makes it incredibly important to human health – it coagulates when exposed to bacterial endotoxins, which can cause sickness or even death in humans.

The impact of the amebocyte collection process on the crabs, and what should be done about it, is contested. The main challenges and complexities include the endangered Asian horseshoe crab, protection of the Atlantic horseshoe crab population, ecological concern over interdependencies and contested data of mortality rate from amebocyte collection.

While the demand for endotoxin testing continues to increase globally with no indication of consumption decline, the availability of synthetic alternatives is also growing in availability and popularity driven in part by ethical and environmental concerns about pharmaceutical supply chains. Challenges vary regionally in terms of regulation, environmental impact, cost and accessibility.

A survey amongst PSCI members was conducted intending to take the pulse of member companies which carry out or commission endotoxin tests, establishing their corporate policies and plans for TAL and LAL usage, as well as their current practices. Going forward, it is imperative to realize that the pharmaceutical industry must come together to collaborate on opportunities in this area.

This project was funded through the projects workstream. Following report publication, the working group aims to publish further capability building resources to support good practices amongst PSCI members. While members are progressing on developing positions on the reduction or elimination of TAL and LAL in their supply chains, only few are be planning for the resilience of its supply.

The PSCI would like to extend a big thank you to Jay Bolden and Shah Shaid, members of the Horseshoe Crab Blood Working Group, the PSCI member companies that responded to the survey and all other contributors for the development of this year’s report.