Allen Burgenson, associate director, Global Subject Matter (SME) Testing, Lonza, discusses the a more sustainable route to future-proof testing and quality control in pharma.
Key insights:
- The industry is increasingly looking to more sustainable BET methods — to minimise supply chain risk and future-proof pharmaceutical quality control (QC) testing operations.
- Research has shown that the rFC method is a suitable BET assay for the products tested, providing a sustainable alternative BET method, and that rFC assays can be comparable to LAL-based methods across various product matrices.
- Eli Lilly’s Emgality was the first FDA-approved drug released using rFC, back in 2018. Since then, regulatory bodies around the world have approved many other drugs tested using rFC.
Traditional LAL-based testing — risks for the modern QC lab
Testing injectables and parenteral pharmaceuticals for bacterial endotoxins is critical for their safe release to the market. Traditionally, the test of choice for bacterial endotoxin testing (BET) has been the limulus amebocyte lysate (LAL) test, which requires the blood of the horseshoe crab (HSC).