We use cookies to make your experience better. To comply with the new e-Privacy directive, we need to ask for your consent to set the cookies. Learn more.
Endotoxin Control Across the Antibody Manufacturing Workflow
Production of antibody therapeutics requires endotoxin control at multiple stages—not just final release. From upstream processing to final quality control (QC), each step introduces different risks, sample types, and testing challenges. The FUJIFILM Biosciences pyrogen and sterility testing portfolio is designed to support each stage for consistent, scalable, and compliant control throughout the entire workflow.
What Matters
Upstream and Process Development
Detect early — Identify endotoxin contamination in raw materials and upstream processes before it impacts production.
Detect early — Identify endotoxin contamination in raw materials and upstream processes before it impacts production.
- Early detection
- High-quality cell culture media and raw materials
- Reliable results for complex or variable matrices
Downstream Processing and In-process Control
Monitor throughout — Verify endotoxin control across purification and manufacturing with reliable in-process testing.
Monitor throughout — Verify endotoxin control across purification and manufacturing with reliable in-process testing.
- Process monitoring throughout
- Reliable purification, concentration, and formulation intermediates for protein-rich environments
- Reduce false positives and negatives
Final Product Quality Control
Confirm at release — Support confident batch release with reproducible testing aligned with global pharmacopoeial requirements.
Confirm at release — Support confident batch release with reproducible testing aligned with global pharmacopoeial requirements.
- Release testing that aligns with regulatory guidelines
- High-throughput capabilities
- Reproducibility across runs and sites
Needs
- Early detection
- High-quality cell culture media and raw materials
- Reliable results even for complex or variable matrices
Solutions
PYROSTAR Neo+
Animal-free, highly sensitive detection of up to 0.001 EU/mL and reduced lot-to-lot variability for consistent development data
Learn MoreCMD αBET System
Minimizes interference from complex biological samples and enables testing with less dilution and higher confidence
Learn MoreNeeds
- Process monitoring throughout
- Reliable purification, concentration, and formulation intermediates for protein-rich environments
- Reduce false positives and negatives
Solutions
PYROSTAR ES-F
High specificity with reduced beta-glucan reactivity. Ideal for protein-based samples in purification workflows and designed for high-throughput QC environments with a strong alignment to compendial methods
Learn MoreCMD αBET System
Minimizes interference from complex biological samples and enables testing with less dilution and higher confidence
Learn More
PYROSTAR ES-F
High specificity with reduced beta-glucan reactivity. Ideal for protein-based samples in purification workflows and designed for high-throughput QC environments with a strong alignment to compendial methods
CMD αBET System
Minimizes interference from complex biological samples and enables testing with less dilution and higher confidence
Needs
- Release testing aligning with regulatory guidelines
- High-throughput capabilities
- Reproducibility across runs and sites
Solutions
PYROSTAR Neo+
Animal-free, highly sensitive detection of up to 0.001 EU/mL and reduced lot-to-lot variability for consistent development data
Learn MorePYROSTAR ES-F
High specificity with reduced beta-glucan reactivity. Ideal for protein-based samples in purification workflows and designed for high-throughput QC environments with a strong alignment to compendial methods
Learn MoreUpstream & Process Development
Cell culture media, raw materials
What matters
-
Detect low-level endotoxin early
-
Handle complex or variable matrices
-
Support process optimization and troubleshooting
Pyrostar Neo+
-
Animal-free, highly sensitive detection (down to 0.001 EU/mL)
-
Reduced lot-to-lot variability for consistent development data
CMD aBET System
-
Minimizes interference from complex biological samples
-
Enables testing with less dilution and higher confidence
Downstream Processing & In-Process Control
Purification, concentration, formulation intermediates
What matters
-
Reliable results in protein-rich environments
-
Reduced false positives/negatives
-
Consistency across batches
Pyrostar ES-F
-
High specificity with reduced $\beta$-glucan reactivity
-
Ideal for protein-based samples in purification workflows
CMD aBET System
-
Overcomes interference in complex matrices
-
Improves data reliability without excessive sample dilution
Final Product QC & Batch Release
Drug substance / drug product release testing
What matters
-
Regulatory compliance (USP <85>, EP 2.6.14, JP)
-
High-throughput capability
-
Reproducibility across runs and sites
Pyrostar ES-F Plate
-
Designed for scalable, high-throughput QC environments
-
Strong alignment with compendial methods
Pyrostar Neo+
-
Supports transition toward recombinant, animal-free testing (<86>)
-
Stable performance with low background variability
How We Help
PYROSTAR Neo+
As regulatory expectations evolve toward animal-free testing, PYROSTAR Neo+ provides a recombinant endotoxin detection option compatible with microplate workflows and aligned with USP <86> Bacterial Endotoxin Testing Using Recombinant Reagents. PYROSTAR Neo+ can serve as a forward-looking alternative or bridging method alongside established LAL testing strategies.
- Highly sensitive detection (down to 0.001 EU/mL)
- Reduced lot-to-lot variability for consistent development data
- Supports transition toward recombinant, animal-free testing (<86>)
PYROSTAR ES-F/Plate
PYROSTAR ES-F/Plate supports reliable, efficient testing of high sample volumes in antibody production. Unlike conventional LAL reagents that may cross-react with (1→3)-β-D-glucan, its endotoxin-specific detection helps reduce false positives and streamline BET workflows in QC laboratories.
- Enables high-throughput endotoxin testing
- Supports parallel processing of multiple QC samples
- Provides trusted compendial alignment
CMD αBET System
The αBET Rapid Endotoxin Detection System supports rapid, in-process, and point of use testing for complex materials. The αBET system utilizes a cartridge-based testing methodology, allowing for small volumes to be tested with quantitative results in less than 30 minutes.
- Enables rapid results for low sample volumes with FDA 21 CFR Part 11 compliance and quantitative reports in less than 30 minutes
- Near-infrared detection wavelength is able to overcome common interferences from complex samples
- Portable and lightweight for point of use testing at any stage of development
Featured Solutions
PYROSTAR Neo+
Animal-free recombinant endotoxin detection reagents for high-sensitivity, endotoxin-specific assays
LumiMAT Pyrogen Detection Kit
In vitro test that detects both endotoxin and non-endotoxin pyrogens
RiboNAT Rapid Sterility Test
Rapid sterility testing solution delivering results in as little as seven hours
CMD αBET System
Fully integrated LAL testing system for rapid and sustainable endotoxin testing in under half the time as other methods
