ENDOXPERTS™ Services
Expert Solutions for Low Endotoxin Recovery (LER) and rFC Testing
ENDOXPERTS™ delivers industry-leading expertise for endotoxin testing and LER mitigation. Our specialized team supports feasibility studies for recombinant Factor C (rFC) methods, develops custom demasking strategies, and ensures regulatory-compliant workflows for pharmaceutical drugs and medical devices, as well as biologics and biosimilars. Using proprietary technologies and extensive expertise, we help optimize analytical workflows for regulatory compliance and product safety. Our team develops robust, tailored methods to support both in-process control and final product release, ensuring accurate, reproducible results for ensuring patient safety.
- Overview
- Services
- Resources
Overview
QC microbiology labs today face mounting challenges in endotoxin testing —juggling high sample volumes, tight timelines, and an ever-evolving regulatory landscape. The validation of new endotoxin testing methods for complex products, especially biologics, often becomes an additional workload that teams are simply not resourced to manage.
At ENDOXPERTS™, we take the guesswork out of endotoxin detection. Our team of specialists supports you without draining internal resources, supporting feasibility studies for recombinant Factor C (rFC) methods, developing custom demasking strategies, and ensuring regulatory-compliant workflows for biologics and biosimilars.
Whether you're dealing with Low Endotoxin Recovery (LER) or struggling with matrix-related interferences, we design tailored demasking strategies and testing conditions that suit your product’s unique profile. For biologics in particular, where regulatory expectations can be especially complex, having a team of experts on your side makes the difference between delay and success.
With advanced technologies like ENDO-RS® and ENDOLISA®, we go beyond conventional methods to offer reproducible and sensitive solutions—even in the most interference-prone matrices. And we don’t stop at method development: we offer interpretation support, troubleshooting, and training to ensure your QC lab runs smoothly and your team stays focused on high-impact tasks.
At ENDOXPERTS™, we don’t just deliver methods: we deliver peace of mind.
Services
Custom Demasking Strategies to Overcome LER:
We specialize in developing custom demasking protocols to address Low Endotoxin Recovery (LER) challenges in biologics and biosimilars. We address endotoxin masking using proprietary kits like ENDO-RS® and ENDOLISA®, enabling recovery even in matrices with polysorbates, surfactants, or citrate buffers.
Our mitigation strategies for LER ensure effective demasking, allowing reliable endotoxin detection in compliance with regulatory expectations and FDA guidance. Since biopharmaceutical formulations vary in composition and concentration, an optimized analytical procedure for LER is developed for each product. By leveraging our expertise and using our specialized kit for demasking, we help clients overcome Low Endotoxin Recovery, enabling accurate endotoxin detection and improving regulatory compliance.
Endotoxin Testing Feasibility for Biologics and Biosimilars:
We conduct and report time-dependent endotoxin spiking studies with undiluted drug product lots according to regulatory requirements to verify the reliability of the used endotoxin assay. The drug product lots are spiked with specified endotoxin levels and held for several days, depending on the sample, before being assayed. Our feasibility studies for rFC assay suitability help ensure method robustness without exhausting internal lab resources. A decline in endotoxin concentration over time is indicative of LER phenomenon.
Endotoxin Testing Feasibility Studies:
Build a robust routine method, but without the burden. Our team of experts helps you develop a reliable endotoxin testing strategy tailored for routine use, eliminating the internal workload of suitability testing and method optimization. We handle the process of feasibility studies so your team can focus on running tests, not designing them.
Regulatory-Compliant Validation of rFC Methods:
Our method validation services ensure the reliability and reproducibility of recombinant Factor C (rFC) assays for endotoxin detection. While pharmacopoeias such as USP and Ph. Eur. have paved the way for the adoption of rFC, in other regulatory environments it is still considered an alternative method, requiring additional validation steps. In these regulatory environments, beyond the essential documentation—such as the Primary Validation Package—bioMérieux offers comprehensive full method validation services. By validating your rFC method under controlled conditions, we provide confidence in its suitability for routine endotoxin testing, while supporting regulatory submissions and quality assurance across global markets.
Resources
ENDOXPERTS™ Brochure
Download
- Filename
- BROCHURE_ENDOEXPERT.pdf
- Size
- 531 KB
- Format
- application/pdf
- Low Endotoxin Recovery: Assessment of PDA Technical Report No. 82
- Low Endotoxin Recovery
- Low Endotoxin Recovery
- BACT/ALERT<sup>®</sup> 3D sterility testing
- BACT/ALERT<sup>®</sup> 3D sterility testing
- Filename
- BROCHURE_ENDOEXPERT.pdf
- Size
- 531 KB
- Format
- application/pdf
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