More and more pharmaceutical companies are adopting innovative technologies to meet constantly changing regulatory requirements while building more sustainable operating models.Endotoxin testingIt is a typical representative of this transformation, as regulatory pressures and sustainable development demands are reshaping the landscape of the bacterial endotoxin testing field. The EU GMP Appendix I encourages the simplification of production processes through technological advancements, while the recent release of recombinant endotoxin testing reagents by the United States Pharmacopeia (USP)<86>provides an important opportunity to achieve regulatory compliance and sustainable development goals.

For these reasons, Sievers analyzer collaborates with Eli Lilly and Company to useSievers^®Eclipse bacterial endotoxin detectorComparative study on the detection results of traditional horseshoe crab reagent (LAL) and novel recombinant cascade reagent (rCR). This instrument utilizes microfluidic technology and centripetal force,Shorten the preparation time for traditional 96 well plate testing to 85% of the original; Reduce the usage of horseshoe crab reagents or recombinant reagents by up to 90%; And achieve automated sample addition of reagentsIn addition to improving efficiency, the system can also ensure the accuracy and reliability of detection results, helping manufacturers meet both the requirements of Appendix 1 and sustainable development goals, while ensuring patient safety in compliance with regulatory requirements.

This study summarizes the results of endotoxin testing using data obtained from real-world samples and provides a practical comparison between two types of reagents.

This study has two objectives. The primary objective is to evaluate the detection and recovery rates of natural endotoxins (NOE) and purified water with added endotoxin reference standards (RSE). This evaluation used two different detection methods: traditional horseshoe crab reagent (LAL) and recombinant cascade reagent (rCR), with the aim of demonstrating that both detection methods can achieve reliable endotoxin recovery.

Another goal is to validate these performance indicators through challenging testing using two types of reagents on the Sievers Eclipse bacterial endotoxin detector. This verification is particularly crucial, as its purpose is not only to demonstrate that the system is suitable for actual sample detection, but also to bring two significant advantages:Reduce reagent consumption by 90% and enable the use of recombinant reagents, thereby promoting the industry to implement more sustainable testing solutions.

The following samples were used in the comparative study of horseshoe crab reagent (LAL) and recombinant cascade reagent (rCR):

Figure 1: Comparison of natural endotoxins (NOE)

The following figure provides a detailed explanation of the positive product control (PPC) recovery rates for samples and reagents.

Figure 2: Comparison of Recovery Rates between Samples and Reagents

This study indicates that,When using Sievers Eclipse to detect bacterial endotoxins and natural endotoxins in real samples, the performance of LAL and rCR is comparableBased on existing evidence, it can be confirmed that the Sievers Eclipse bacterial endotoxin detector can successfully apply recombinant cascade reagents for detection, provided that the compatibility of the validated samples has been verified.

The automation achieved through Eclipse's centripetal microfluidic platform provides the most convenient microfluidic solution for bacterial endotoxin detection, which can significantly save time and reduce the possibility of errors. The application of this innovative technology optimizes the process of bacterial endotoxin testing while complying with pharmacopoeia standards.