A strategic approach to optimisations of testing bacterial endotoxins

Given industry’s recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise. They also explore some of the short-term benefits already realised through the company-wide rollout of their work.

The topic of bacterial endotoxin testing (BET), while a unique requirement for the pharmaceutical industry, has far‑reaching impact. In recent years, articles on the reliance on the horseshoe crab within the pharmaceutical industry1-3 and considerations for alternative testing strategies have been widely discussed.4-7 Here, the approach taken at AstraZeneca to optimise test methodology to provide assurance of patient safety, reduce the burden on a natural resource and continue to improve in this area is shared.

The endotoxin test typically utilises the lysate refined from the blood of the horseshoe crab; this article addresses the approaches AstraZeneca has taken to minimise the burden on this natural resource. This work considers the United Nations (UN) Sustainable Development Goals (SDG), as well as the importance of change management in a heavily regulated laboratory environment, to provide support and ensure patients receive safe and efficacious products.