ENDONEXT™
THE EVOLUTION OF ENDOTOXIN TESTING
Inaccurate or inconsistent endotoxin results can compromise product safety and quality, leading to potential regulatory issues, increased operational costs, and more importantly, risking patients’ safety.
These risks explain why laboratories are seeking reliable, efficient, and environmentally friendly endotoxin testing solutions that can apply to various sample types and testing requirements.
ENDONEXT™ endotoxin detection assays are ushering in a new era of smarter, more sustainable pharmaceutical quality control.
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- ENDOLISA Endotoxin testing
- Overview
- Tests
- Integration
- Services
- Resources
Based on recombinant Factor C (rFC), ENDONEXT™ technology not only eliminates the need to harvest horseshoe crab blood, but also makes your laboratory 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 complex matrices.
Traditional endotoxin testing methods often require heavy manual preparation, are prone to interferences, and may not be suitable for all types of samples — leading to inefficiencies, increased costs, and inaccurate results.
In light of the global environmental awakening, methods requiring horseshoe crab blood raise sustainability and ethical concerns that are not aligned with companies' corporate social responsibility (CSR) initiatives. However, newer recombinant cascade methods, are still very new and lack peer-reviewed data and regulatory approval.
Our recombinant Factor C (rFC) assay:
- has over 20 years of data
- is mentioned in the European Pharmacopoeia (EP) chapter 2.6.32 since 2020
- and in the new United States Pharmacopeia (USP) chapter <86> draft.
The ENDONEXT™ portfolio offers innovative reagents to support you in streamlining your endotoxin testing process, ensuring accurate and consistent results while reducing hands-on time and waste. With proven performance and regulatory acceptance, our solutions provide confidence and reliability.
Benefits
- 100% endotoxin specificity
- High lot-to-lot consistency
- Decrease in hands-on time so you canrun your lab more efficiently
- Sustainability — no dependence on a unique animal source
- Validated according to standard pharmacopoeia Bacteria Endotoxin Testing criteria
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