BETTER FOR YOUR LAB.BETTER FOR THE PLANET.ENDONEXT™ endotoxin detection assays from bioMérieux are ushering in a new era of smarter, more sustainable pharmaceutical quality control.

Based on Recombinant Horseshoe Crab Factor C (rFC), ENDONEXT™ technology not only eliminates the need to harvest horseshoe crab blood—it makes your entire lab more efficient. With 100% endotoxin specificity, lot-to-lot consistency, and more streamlined workflows, ENDONEXT™ provides reliable results everywhere from in-process controls to final product testing on the most challenging matrices.

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Key differentiator: GOPLATETM

Conventional microplate-based bacterial endotoxin tests require time consuming preparation of endotoxin standard dilutions and internal controls. Extensive manual handling fosters substantial variability and invalid results. To address these points, a fi rst-of-its-kind microplate, GOPLATE, has been developed, embedding the required Control Standard Endotoxin (CSE) and positive product controls (PPC) in dried format. Rendering the standard preparation step completely obsolete, the GOPLATE enables a signifi cant reduction of handling-time, greatly improved consistency and robust results. Importantly, it lowers the risk of invalid results and thereby minimizes the need for cost intensive test repetition.

■ More than 50% reduction in handling time compared to conventional microplate assays

■ High assay accuracy, precision, and linearity of standard curves

■ Signifi cant reduction in handling errors, OOS and investigations

■ Suitable for automation and high through-put testing

■ Ideal for in-process control and fi nal product testing

■ Fulfi lling all pharmacopoeia requirements

Learn more about bioMérieux endotoxin products and services, visit: biomerieux-industry.com/Endotoxin

Introducing ENDOZYME® II GO, endotoxin testing made faster, easier and more consistentThe rapid ENDOZYME® II GO assay is the latest member of bioMérieux’s ENDONEXTTM range of endotoxin detection assays based on sustainable recombinant horseshoe crab Factor C (rFC). The new assay caters to two important needs: effi ciency and consistency.

All required reagents and water are included in the ENDOZYME® II GO kit

Test specifi cationsENDOZYME II GO is a 96-well end point fl uorescence assay, also ideal for automation and parallel performance of several plates:

■ 100% endotoxin specifi city, no cross-reaction with glucans

■ Limit of detection: 0.005 EU**/mL ■ Assay run time: 20 min (0.05 EU/mL),

60 min (0.005 EU/mL) ■ Required equipment: Fluorescence

reader, 21 CFR part 11- compliant calculation software, endotoxin-free accessories.

** 1 EU, Endotoxin Unit, corresponds to 100 pg endotoxin

Supplier validation studyENDOZYME II GO was validated as analytical procedure according to the ICH guideline Q2 (R1) and USP <1225>. Accuracy, precision, specifi city, quantitation limit, linearity, range and robustness were demonstrated to fulfi ll the acceptance criteria and documented in a method validation report (P. Schneider et al). Linearity means the capability to achieve an assay readout which is directly proportional to the endotoxin concentration.

ENDOZYME II GO consistently (n = 20) returned correlation coeffi cients |r| of 1.000, the maximum achievable value. This demonstrated perfect linearity and highly exceeded the minimum 0.980 as per the harmonized chapters on the Bacterial Endotoxin Test. Lot-to-lot comparison of three lots, in total 20 GOPLATEs values are depicted below, further confi rming the high level of consistency of the ENDOZYME II GO assay.

Comparison of manual preparation time*, case study of full 96-well plate with undiluted samples in duplicates:

Streamlined workfl ow with few and easy steps1. Add water to the

standards, negative and positive control wells (wells A1-H2).

2. Add 100 µl sampleinto 4 wells each (duplicate testsand PPCs).

3. Prepare and add the assay reagent to the GOPLATE, followed by a short incubation and start of measurement in the fluorescence reader.

* Exact preparation times depend on sample types; need for dilution, equipment and operator

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