Living diagnostics

With the introduction of new guidances and the endorsement of USP has not only provided a clear support for rapid microbiological methods, but it has also issued a challenge to the wider industry – pushing pharmaceutical companies are encouraged to innovate beyond current expectations by embracing processes that can deliver much faster testing results without compromising on safety and compliance. 

When faced with a potentially contagious respiratory disease, the history and physical examination are obviously the first steps in evaluating the situation. However, laboratory testing remains essential to detect and identify the pathogens responsible for the infection, and thus confirm the risk of spreading to other horses. In such urgent situations, the key question is: are all tests really equivalent ?

Escherichia coli (known as E. coli) are typically harmless bacteria that naturally occur in the intestines of humans and animals. Some strains of E. coli, however, can be incredibly harmful. One such strain is Shiga toxin-producing E. coli (STEC), which if ingested can create dangerous toxins that can lead to serious infections.

Could 2025 be the year that endotoxin testing finally catches up with the 21st century? Unlike other areas of Pharmaceutical Quality Control where innovations such as data analytics and automation have driven extensive modernization, endotoxin testing has remained resolutely stuck in the past. This vital Quality Control procedure has until recently relied on outdated testing practices that require the blood of horseshoe crabs. Significantly, new authoritative standards have recently recognized alternative testing methods that can deliver the same important validation, without relying on animal-derived products. What are these new standards and what could their integration mean for the future of endotoxin testing?