ENDONEXT™

The Evolution of Endotoxin Detection

At the frontier of endotoxin testing with recombinant technology.

One of our main missions is to innovate in the field of endotoxin detection, with a strong focus on patient safety. Our ENDONEXT™ Endotoxin Detection Assays based on recombinant Horseshoe Crab Factor C (rFC) give you the performance needed for fast and efficient in-process control, product release and solutions for even the most challenging matrices throughout your manufacturing process. Using synthetic rFC instead of blood cells from Horseshoe crabs not only ensures ecological sustainability and security of supply, but also unprecedented accuracy, sensitivity and lot-to-lot consistency.

Main Benefits :

●   100% endotoxin specificity, no false positives from ß-Glucan or interference due to colored or turbid samples.
●   Approved for use and validated in the same way as LAL (limulus amebocyte lysate) , following pharmacopoeia BET (Bacterial Endotoxin Test) chapters.
●   Higher precision and rate of valid results combined with time-saving sensitivity and lot-to-lot consistency.

➔ See the video

Features

100% endotoxin specificity, no false positives from ß-Glucan or interference due to colored or turbid samples.

Higher precision and rate of valid results combined with time-saving, state-of-art sensitivity and lot-to-lot consistency.

Easy automation with commercially available robotic liquid-handling systems.

Ecological sustainability & security of supply with rFC instead of using an animal source.

Cost efficiency with short Return of Investment (ROI) and reduced waste fulfilling 3R principles.

Fluorescence end-point assays in 96-well microplate format with methodologies similar to kinetic chromogenic LAL.

Approved for use and validated in the same way as LAL, following pharmacopoeia BET chapters.

Tests

We’re making endotoxin testing faster, easier and more ecologically friendly by mimicking nature, not exploiting it. Our assays enable confident in-process control and product release decisions of pharmaceutical products and medical devices.

Explore the ENDONEXT™ range of time and cost-saving methods (.pdf) ➔

ENDOZYME® II GO

The rapid GO version of ENDOZYME®II featuring GOPLATE™—a microplate pre-filled with required standard curve and positive product control concentrations (PPC).

• Eliminates manual preparation of standard dilutions and PPCs

• Over 50% reduction in handling time compared to conventional microplate assays

• Significantly reduces risk of error

• Ideal for in-process control of water and raw materials as well as product release testing

• Easy automation

ENDOZYME® II

The enhanced second generation of ENDOZYME® is a flexible and easy-to-use endotoxin detection assay.

• State-of-the-art sensitivity down to 0.001 EU/mL

• Flexible assay time depending on required sensitivity

• Particularly suited for final product testing, formulation and research

ENDOLISA®

With its unique built-in sample preparation step, the ENDOLISA® assay revolutionizes endotoxin testing of complex samples.

• ELISA-like format features 96-well plate pre-coated with a specific endotoxin-binding phage protein

• Overcomes limits of traditional methods such as inhibition and enhancement

• Unprecedented tolerance of organic solvents, detergents

Features

ENDOGRADE^® Water

Ultra-pure water for reconstitution and dilution of test samples and reagents. Certified to contain less than 0.001 EU/mL and ideal for preparing solutions and reagents for bacterial endotoxin testing.

BioTek Synergy™ HTX Multi-Mode

Microplate Reader Instrument with filter-based fluorescence and monochromator-based UV/Vis absorbance read-out, fluorescence mode ideal for running the ENDONEXT™ endotoxin detection assays. Linear and orbital shaking, temperature control, powerful Gen5 Secure Software, 21 CFR part 11, for reader control and all data reduction needs.

ENDOGRADE^® Glass Test Tubes

Endotoxin-free borosilicate glass test tubes with aluminum screw cap for samples and the dilution of endotoxin standards contained in the ENDOZYME^® II and ENDOLISA^® kits. Manufactured according to a dry heat depyrogenation procedure.

Support