The widespread use of horseshoe crab blood to produce lysate for endotoxin testing in the biomedical industry presents significant environmental and ethical challenges due to its potential impact on crab populations. This has led to a shift toward more sustainable and ecologically responsible practices by reducing reliance on crab lysate; thereby protecting a dwindling species and emphasising environmental protection as a priority.

Horseshoe crabs are integral to coastal ecosystems, aiding in nutrient cycling and supporting migratory bird populations. Reducing crab harvesting helps preserve biodiversity and ecosystem health, aligning with ethical resource use and global sustainability goals such as the UN Sustainable Development Goal 14, which emphasizes the conservation of marine resources. By adopting crab lysate reduction, we can protect marine biodiversity and promote sustainable industry practices in our manufacturing work-streams; embedding sustainability into every aspect of our supply chain.

Endotoxin testing is crucial for ensuring the safety and efficacy of pharmaceutical drugs, as endotoxins from Gram-negative bacteria can lead to severe reactions in humans, if present in these products, particularly in injectables. Complying with safety standards set by regulatory agencies such as the FDA and EMA is mandatory, making endotoxin testing an integral part of quality control. This practice prevents contamination, safeguards public health, and maintains trust between pharmaceutical companies and healthcare providers by ensuring consistent product quality and integrity.

At AstraZeneca (AZ), we are implementing global strategies to decrease and eventually eliminate reliance on crab lysate. Whilst this drives our sustainability agenda, it simultaneously enhances productivity, compliance, and reduces testing costs; aligning to our company goal of making our goods more accessible to patients around the world.

Annually, pharmaceutical waters undergo a substantial volume of testing with over 30,000 samples. The introduction of automation and cartridge-based systems in recent years has yielded significant benefits across our laboratory network, including:

– Environmental benefits linked to a 95% reduction in crab lysate usage by adopting a microfluidic cartridge system, compared to the traditional large-volume plate reader technology.
– Access to medicines benefits through reduction in testing time, removing 3,000 hours of analyst hands-on time per year.
-Savings of $350,000 in reagent costs annually, reducing our cost of goods and making our products more affordable and more sustainable.

AstraZeneca Operations Labs are embracing alternative technologies, such as recombinant lysate reagents. We have successfully evaluated several recombinant platforms as viable alternative methods for endotoxin testing and aim to complete the transition for pharmaceutical water testing by the end of 2025. Efforts are ongoing to ensure that new products are developed using these synthetic alternatives for testing, with strategies in place to transition legacy product samples to recombinant methods. This initiative reflects our commitment to sustainable practices, cost efficiency, and environmental stewardship in pharmaceutical testing.