(1313-B) Holy Crab! Automated Bacterial Endotoxins Platform for Pharmaceutical Quality Control Testing

Abstract: Testing materials for bacterial endotoxins is a global regulatory expectation. Historically, the available options for conducting such testing relied on animal-based assays, involving either rabbits by USP Chapter < 151> or Limulus Amebocyte Lysate (LAL) derived from horseshoe crabs as per the harmonized USP Chapter < 85>. A recent development introduces a novel testing method utilizing recombinant Factor C (rFC), as outlined in the European Pharmacopoeia (Ph. Eur. 2.6.32). This innovation reduces dependence on animal-derived techniques.

Comparable to the LAL assay, the rFC test activates Factor C through endotoxin binding, mirroring the reaction pathway of the traditional method. In the rFC assay, the activated recombinant Factor C initiates a reaction wherein a fluorogenic substrate generates a fluorescent signal proportional to the concentration of endotoxin detected. This advancement signifies a paradigm shift towards a more sustainable and animal-friendly approach in bacterial endotoxin testing.

As an early adopter of rFC testing, no automated platform was available for high-throughput sample processing. A strategic initiative arose to deliver a fully automated platform to standardize the Lilly global quality laboratories. The primary goal was to yield a transformative impact on laboratory operations, with anticipated benefits including a substantial reduction in hands-on time, mitigated test variance between analysts, decreased failure rate, and diminished ergonomic risks.

Our approach involved leveraging robotic partners to develop an integrated robotic solution. The comprehensive solution encompasses end-to-end sample management, from initial barcode tracking and monitoring of material quantities to method execution, data analysis, and the generation of endotoxin results, accompanied by relevant metadata. The integration of this automated platform is strategically designed to drive standardization across laboratory processes, ensuring consistency, efficiency, and heightened reliability in sample testing and analysis. Furthering, the vision is to elevate laboratory workflows by introducing technologically advanced solutions that optimize operational efficiency and enhance the quality and reliability of laboratory results.

In conclusion, integrating robotic technologies is a holistic solution that delivers tangible value by addressing critical factors such as increased capacity, improved efficiency, reduced variability, and enhanced quality within the organization.