Sustainability. Efficiency. Consistency.
Tessa Patton, Manager, Bio/Pharmaceutical Microbiology, Eurofins BioPharma Product Testing
When you hear the words sustainability, efficiency, and consistency, do you immediately think of bacterial endotoxin testing? I must admit, it’s not the first thing that used to come to my mind when I hear those words. Sometimes Bacterial Endotoxin Testing can feel like anything but sustainable, efficient, or behave consistently, but with new methodology and technology available in the industry, Bacterial Endotoxin Testing is a whole new ballgame.
In the complex world of pharmaceutical quality control, BET plays a critical role in ensuring the safety of drugs, vaccines, and medical devices. Eurofins BioPharma Product Testing’s team is excited to onboard new methodology and technology, providing practical solutions to deal with the challenges of Bacterial Endotoxin Testing. Onboarding bioMérieux’s Recombinant Factor C (rFC) reagent, as well as the Sievers Eclipse™ Bacterial Endotoxin Testing Platform for Kinetic Chromogenic testing allow Eurofins BPT to demonstrate its commitment to sustainability, improved workflow efficiencies, and ensure consistency within the data we provide.
bioMérieux’s rFC is part of their ENDONEXT™ technology and is a non-animal-derived alternative to the traditional limulus amebocyte lysate (LAL). rFC mimics the natural Factor C that is found in horseshoe crab blood, binds specifically to endotoxin, which triggers a cascade reaction resulting in a measurable signal (either fluorescence or luminescence). The use of a synthetic reagent reduces lot-to-lot variability, which in turn allows for more consistent performance. Eurofins BPT has selected bioMérieux’s ENDOZYME® II GOPLATE™ technology to further improve consistency, as well as improve workflow efficiency. The GOPLATE comes pre-filled with required standard curve and positive product controls, which aids in reducing analyst time and eliminating analyst-to-analyst technique variability. This new technology is compliant with USP <86> and EP 2.6.32.
While not completely eliminating the use of traditional LAL, the Sievers Eclipse Bacterial Endotoxin Testing Platform does significantly reduce the use of LAL by up to 90% when compared to the traditional Bacterial Endotoxin methods. Similar to the bioMérieux’s ENDOZYME II GOPLATE, the Eclipse utilizes a microplate that comes pre-loaded with the standard curve and positive product controls, again reducing analyst hands-on time and eliminating variability due to analyst technique. The Eclipse utilizes microfluidics and automation to streamline workflow. The Eclipse does all of this while maintaining compliance to USP <85>, EP 2.6.14, and JP 4.01.
Implementation of ENDONEX and Sievers Eclipse platforms demonstrates Eurofins commitment to innovation, compliance, and sustainability while providing multiple alternatives to our clients for their Bacterial Endotoxin Testing needs. These innovations are not only optimizing workflows but also having a meaningful impact on how the industry continues to advance. While Bacterial Endotoxin Testing is a cornerstone of patient safety, other microbiological tests are as critical to ensuring safety of products, thus creating opportunities to evaluate other advancements in microbiological testing. As the pharmaceutical industry continues to evolve, implementing technologies that lend to efficiency gains, reducing variability, and supporting sustainability is vital.