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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.

ENDOLISA Endotoxin testing

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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ENDONEXT®: Eliminates the need to harvest horseshoe crab blood and helps make quality control more precise and efficient.  

Tests

At bioMérieux, we understand your need for consistent and reliable endotoxin testing. You can achieve faster, easier and environmentally friendly QC testing programs!

ENDOZYME® II GO

Accuracy and ease of use are your main priority. By decreasing the hands-on time by 50%, our GO plates allow you to speed up testing and to reduce the risk of error that can delay your processes.

  • Eliminates manual preparation of standard dilutions and PPCs with pre-filled GOPLATETM
  • Over 50% reduction in handling time compared to conventional microplate assays
  • Significantly reduces the risk of error
  • Ideal for in-process control of water and raw materials and product release testing
  • Easy automation

ENDOZYME® II GO STRIPS

Flexibility should not compromise with waste and cost management. Laboratories do not always have 20 samples to fill a full plate! ENDOZYME® II GO STRIPS were designed with flexibility in mind:

  • Flexibility to test anywhere from one to 21 samples with minimal waste
  • Consistency in use with CSE pre-coated wells
  • + all the benefits of our traditional  ENDOZYME® II GO products!

 

ENDOZYME® II

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

  • Accute 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

Seamless IT Integration & Dedicated Software

Our experts ensure a smooth integration of our software into your existing IT infrastructure, providing comprehensive support to maximize your lab's efficiency, security, and compliance.

  • Peace of mind: Our 21 CFR Part 11 enabled software ensures compliance with regulatory standards, providing confidence in your data integrity program and security.
  • Streamlined workflow: Electronic signature and audit trail functionalities simplify approval processes and enhance traceability.
  • Enhanced security: User management with LDAP integration ensures strict access control, protecting sensitive data.
  • Data protection: Automated backup processes safeguard against data loss or corruption.
  • Efficiency: Installation on your PC, compatibility with corporate antivirus, and seamless network integration ensure smooth operations.
  • Cybersecurity support: Comprehensive cybersecurity measures provide ongoing protection against threats.

Integration Services

Our validation services are tailored to meet the specific needs of pharmaceutical laboratories, assuring that our systems meet regulatory requirements and operate effectively.

  • Comprehensive qualification: Our field application specialists offer Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) services.
  • Regulatory compliance: Ensure compliance with industry standards.
  • Risk mitigation: Identify and control risks associated with software and instrument integration.
  • Documentation: Thorough documentation of qualification processes for audit readiness.
  • Efficiency: Minimize downtime with efficient and timely services.
  • Expert guidance: Experienced specialists guide you through the validation process.

Get the Most With Our ENDOXPERTS™ Services

ENDOXPERTS™ Endotoxin Services by bioMérieux provide routine testing and feasibility studies as well as specialized services for analytical issues such as LER.

Our work for leading pharmaceutical companies has resulted in validated methods for LER, fulfilling regulatory requirements. Applying true scientific soundness, we continue our contribution to the deepened knowledge of the LER phenomenon and complex nature of endotoxin.

Resources

BROCHURE - Creating Value by Harvesting the Full Potential of your Bioprocessing Testing

DISCOVER OUR COMPREHENSIVE PORTFOLIO

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BMX_Bioproduction_Brochure_A4_vF_web.pdf
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7 MB
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application/pdf

   

Brochure - ENDONEXT™

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PHARMA_BROCHURE_ENDONEXT.pdf
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2 MB
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application/pdf

   

Brochure - ENDONEXT™ Software

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BROCHURE_ENDONEXT_SOFTWARE_A4_05_23_9324112.pdf
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2 MB
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application/pdf

   

Brochure ENDONEXTTM Cybersecurity by design

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BROCHURE_CYBERSECURITY_ENDONEXT_A4_12_24_-9328701_Pages.pdf
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8 MB
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application/pdf

   

Brochure - ENDOZYME® II GO Strips

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PHARMA_BROCHURE_EZIIGO_STRIPS.pdf
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2 MB
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application/pdf

   

Citation List - Recombinant Factor C (rFC) Assay

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BMX_rFC_Citation_List_2022.pdf
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74 KB
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application/pdf

Brochure - ENDOZYME® II

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Flyer_ENDOZYME II.pdf
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867 KB
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application/pdf

   

Brochure - ENDOZYME® II GO

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PHARMA_BROCHURE_EZIIGO.pdf
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2 MB
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application/pdf

   

Brochure - ENDOLISA®

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Flyer_ENDOLISA.pdf
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920 KB
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application/pdf

   

Poster - PDA 2023 - Endotoxin Testing for Cell & Gene Therapy Products

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bioMerieux_Poster_PDA_2023_Endotoxins.pdf
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740 KB
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endotoxin testing rfc biomerieux

Revolutionize Your Endotoxin Testing

Embark on a 6-part journey designed to challenge the traditional norms in endotoxin detection.
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Interview with Pr. Ding, Pioneer in rFC endotoxin testing

Expert Interview

Celebrating innovation with Professor Ding: A pioneer in sustainable endotoxin testing

Professor Jeak Ling Ding is a world-renowned pioneer in the field of molecular biotechnology. We spoke with Professor Ding to learn more about her career defining breakthrough to genetically engineer recombinant Factor C, and the importance of creating a sustainable and ethical alternative to replace traditional methods of endotoxin testing. 

Read More

The Hunt for the Missing Endotoxin

This white paper reviews the causes contributing to low endotoxin recovery (LER), the impact it creates, as well as solutions which can rectify the issues it results in. We also discuss the advantages and disadvantages of developing your de-masking protocols in-house, and how you can use the ENDO-RS® de-masking tool kit to make the process easier from beginning to end. Following this, we outline the pros and cons of outsourcing your de-masking project, what you should look for in a third-party company, and why you can and should trust bioMérieux with your de-masking protocol development.
Read More

WHITE PAPER

Adoption of rFC for bacterial endotoxin testing

With industry’s push to build a more diverse global supply chain, we find ourselves at a tipping point for the widespread adoption of alternative solutions like rFC — driven as much by industry, if not more, than regulators.
Read More

WHITEPAPER

Low Endotoxin Recovery case studies

This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference.
Read More

WHITEPAPER

Waste in Endotoxin Detection Assays LAL vs rFC

From traditional to alternate endotoxin testing methods used for product release testing, there is an opportunity to waste less reagent and generate cost savings.

Read More

Explore All Endotoxin Solutions

ENDOZYME® II GO

By significantly reducing hands-on time, ENDOZYME® II GO not only makes your lab more efficient — it reduces the risk of invalid results and reduces laboratory waste by eliminating manual preparation steps that are prone to handling errors.

Learn More

ENDOZYME® II GO STRIPS

Laboratories don’t always need to test all 20 samples to fill a full plate—that’s why ENDOZYME® II GO STRIPS are designed with flexibility in mind: the flexibility to use only what you need, when you need it.

Learn More

ENDONEXT™ Automated with Tecan

We have paired our ENDONEXT® rFC-based endotoxin testing solutions with the Tecan Fluent® automation platform. 

Learn More

ENDOXPERTS™ Services

ENDOXPERTS™ Endotoxin Services by bioMérieux provide routine testing and feasibility studies as well as specialized services for analytical issues such as LER. Our work for leading pharmaceutical companies has resulted in validated methods for LER, fulfilling regulatory requirements. 

Learn More