Bacterial endotoxins and pyrogens (both endotoxins and non-endotoxin pyrogens (NEPs) from bacteria, viruses, yeasts, and molds) are critical quality attributes (CQAs) for parenteral drug products, with a major impact on patient safety. 

In the “3R” perspective, the European Pharmacopoeia (Ph. Eur.) decided to put an end to Rabbit Pyrogen Test (RPT) in 2026. In the same way, endotoxin testing by LAL using animal-sourced lysate (Limulus Amebocyte Lysate) is also being questioned. 

At the cutting edge of analytical sciences, Quality Assistance is constantly investing in the latest technologies and equipment to provide the pharmaceutical industry with up-to-date services required by regulatory authorities and product evolution. To complete our analytical panel for QC testing, we implemented more ethical and sustainable solutions, i.e., the in vitro Monocyte Activation Test (MAT) for pyrogens and recombinant Factor C (rFC). Recently, scientific and technological advancements have unlocked new possibilities for adoption of sustainable alternatives both in endotoxin and pyrogen testing. With this in mind and in accordance with the regulatory evolution (i.e., General notice 6.30, USP draft <86>), evaluation of recombinant LAL cascade reagents (rLAL) will be assessed and investigated as part of our R&D and Innovation portfolio for 2024.