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ENDONEXT™ Automated Endotoxin Testing

UNLOCKING LAB EFFICIENCY

Aligning your laboratory with the future of QC testing programs requires optimization of business processes and ensuring high-quality results.

To support your strategic decision-making, we have paired our ENDONEXT® rFC-based endotoxin testing solutions with the Tecan Fluent® automation platform.

In today’s rapidly evolving environment of biotechnology and pharmaceutical companies, achieving efficient, reliable, and sustainable endotoxin testing is crucial to ensure product safety and compliance with stringent regulatory requirements.

By prioritizing compliance, sustainability, and efficiency, our automation solution helps you optimize QC processes, reduce operational costs, and ensure environmental conservation by eliminating the need for horseshoe crab blood.

EFFICIENCY

  • Reduce hands-on time: extensive automation by over 95%, allowing your team to focus on critical tasks.
  • High throughput quality control: process up to 120 samples in about an hour, achieving results faster than ever with parallel processing. 
  • Increased ROI: flexible and open platform that can adapt to meet your laboratory's specific needs and run additional assays.

 

SUSTAINABILITY 

  • Regulatory compliance: our rFC-based methods are recognized in the European Pharmacopoeia and align with the new USP Chapter <86> draft and support 21 CFR Part 11 requirements.
  • Sustainable practices: align with ethical and sustainable initiatives by eliminating horseshoe crab dependency, reducing waste, and plastic usage.
  • Maintain data integrity: ensure traceability and sustain data integrity through sample tracking, LIMS integration, and electronic signatures.

RELIABILITY

  • Decreased retest rate: pre-coated plates ensure simple handling, reducing errors, retests, and out-of-specification results.
  • Expertise: with over 15 years of experience, benefit from our proven track record in accuracy and reliability.

Seamless Integration

Your team’s time is precious and in the endotoxin testing lab, every minute counts. With bioMérieux and Tecan, you can automate your entire endotoxin testing process, meaning that your skilled professionals can focus on more critical tasks - resulting in overall improved efficiency.

Our ENDONEXT™ endotoxin testing solution deployed on the Fluent® automation platform offers seamless integration with your existing laboratory workflow, ensuring smooth testing from start to finish with reduced manual steps.

From sample preparation to data analysis, this platform simplifies every step of the testing process, allowing you to focus on what matters most: delivering accurate and reliable results. It is an investment in your laboratory’s future, achieving enhanced ROI and increasing your laboratory’s capabilities with our flexible and adaptable solution. 

Graph detailing process

Quality & Compliance

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

  • Compliance: instrument includes hardware, software IQOQ, and method validation for high-quality standards.
  • Enhanced accuracy: the platform is designed for precise sample handling and data integrity, reducing the risk of human error and retests.
  • Facilitated training: comprehensive training programs to help your team efficiently operate the system and maintain high-quality results.
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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™ using the Tecan platform

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Filename
PHARMA_ BROCHURE_ENDONEXT_TECAN_Pages.pdf
Size
2 MB
Format
application/pdf

Brochure - ENDONEXT™

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Filename
PHARMA_BROCHURE_ENDONEXT_A4_05_23_9324113_Pages.pdf
Size
488 KB
Format
application/pdf

Brochure - ENDONEXT™ Software

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Filename
BROCHURE_ENDONEXT_SOFTWARE_A4_05_23_9324112.pdf
Size
277 KB
Format
application/pdf

   

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

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Filename
bioMerieux_Poster_PDA_2023_Endotoxins.pdf
Size
740 KB
Format
application/pdf

Citation List - Recombinant Factor C (rFC) Assay

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Filename
BMX_rFC_Citation_List_2010_2022_Final.pdf
Size
74 KB
Format
application/pdf