Endotoxin trends: sustainability, automation and beyond

Bacterial endotoxin testing (BET) is key in pharmaceutical development/manufacturing, due to the potentially harmful effects that endotoxins can have on human health.¹

BET often utilises Limulus amoebocyte lysate (LAL), refined from the blood of the horseshoe crab, as an in vitro testing assay to detect bacterial endotoxins.¹ While the process was developed in the 1970s and 1980s, there have been several advances over the past few years, with drives to improve sustainability, increase testing speed and leverage automation to minimise deviations.

European Pharmaceutical Review recently spoke to Miriam Guest, Principal Microbiologist at AstraZeneca UK, who has been involved in work to establish a short-, mid- and long-term strategy to optimise BET across the global business.²

AstraZeneca is evaluating a range of testing options and strategies to ensure it has a robust test that can reliably detect endotoxins across different modalities. The company recently adopted a microfluidic cartridge-based endotoxin testing technology primarily for water testing and is looking to qualify the technique for other applications, including in-process controls, input materials, buffers and final product testing.

Here, Miriam discusses priorities for validating new BET methods, including whether autochthonous endotoxins should be considered when evaluating test suitability, as well as how endotoxin testing may evolve with Annex 1³ and other impending industry guidance.