Skip to main content

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.

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.  

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
Please accept targeting cookies to allow Youtube video

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 - ENDONEXT™

Download

Filename
PHARMA_BROCHURE_ENDONEXT.pdf
Size
488 KB
Format
application/pdf

   

Brochure - ENDONEXT™ Software

Download

Filename
BROCHURE_ENDONEXT_SOFTWARE_A4_05_23_9324112.pdf
Size
277 KB
Format
application/pdf

   

Brochure - ENDOZYME® II GO Strips

Download

Filename
PHARMA_BROCHURE_EZIIGO_STRIPS.pdf
Size
483 KB
Format
application/pdf

   

Citation List - Recombinant Factor C (rFC) Assay

Download

Filename
BMX_rFC_Citation_List_2022.pdf
Size
74 KB
Format
application/pdf

Brochure - ENDOZYME® II

Download

Filename
Flyer_ENDOZYME II.pdf
Size
867 KB
Format
application/pdf

   

Brochure - ENDOZYME® II GO

Download

Filename
PHARMA_BROCHURE_EZIIGO.pdf
Size
574 KB
Format
application/pdf

   

Brochure - ENDOLISA®

Download

Filename
Flyer_ENDOLISA.pdf
Size
920 KB
Format
application/pdf

   

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

Download

Filename
bioMerieux_Poster_PDA_2023_Endotoxins.pdf
Size
740 KB
Format
application/pdf