Sustainability. Efficiency. Consistency.
Tessa Patton, Manager, Bio/Pharmaceutical Microbiology, Eurofins BioPharma Product Testing in Lancaster, PA, Tessa.Patton@bpt.eurofinsus.com
The words sustainability, efficiency, and consistency, don’t immediately bring bacterial endotoxin testing to mind. Bacterial endotoxin testing (BET) can feel like anything but sustainable, efficient, or consistent, but new technologies open a whole new arena in BET.
In the complex world of biopharmaceutical quality control, BET plays a critical role in ensuring the safety of drugs, vaccines, and medical devices. The Eurofins BioPharma Product Testing (BPT) team is proud to onboard new technologies and practical solutions to deal with the challenges of BET. Onboarding bioMérieux’s Recombinant Factor C (rFC) reagent and the Sievers Eclipse™ Bacterial Endotoxin Testing Platform for kinetic chromogenic testing, demonstrates our commitment to sustainability, workflow efficiencies, and data consistency.
bioMérieux’s rFC, a part of their ENDONEXT™ technology, is a nonanimal-derived alternative to the traditional limulus amebocyte lysate (LAL). rFC mimics the natural Factor C found in horseshoe crab blood and binds specifically to endotoxin to trigger a cascade reaction, resulting in a measurable signal (either fluorescence or luminescence). This synthetic reagent reduces lot-to-lot variability, resulting in a more consistent performance. Eurofins BPT selected bioMérieux’s ENDOZYME® II GOPLATE™ technology to improve both consistency and workflow efficiency. This aids in reducing analyst time and eliminates analyst-to-analyst technique variability. It’s also compliant with USP <86> and Ph. Eur. 2.6.32.
The Sievers Eclipse Bacterial Endotoxin Testing Platform significantly reduces the use of LAL by up to 90% as compared to traditional BET methods. Similar to the ENDOZYME II GOPLATE, the Eclipse utilises a pre-loaded microplate, again reducing hands-on time and eliminating technique variability. It does all of this while maintaining compliance to USP <85>, Ph. Eur. 2.6.14, and JP 4.01.
Combining these innovations with our expertise has meaningful impact on the industry and the environment. As the biopharmaceutical industry continues to evolve, adopting and developing technologies to increase efficiencies, reduce variability, and support sustainability is vital. For more information, visit: Sustainable rFC Endotoxin Testing | Eurofins BPT.