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
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
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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®
- 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
- The Hunt for the Missing Endotoxin
- The Hunt for the Missing Endotoxin
- Adoption of rFC for bacterial endotoxin testing
- Low Endotoxin Recovery case studies
- Waste in Endotoxin Detection Assays LAL vs rFC
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