Gene therapy products—including AAV and lentiviral vectors—introduce a fundamentally different testing environment.

These therapies often involve:

• Extremely low endotoxin thresholds
• Limited and high-value sample material
• Complex viral and protein-based matrices
• High sensitivity to variability in testing methods

In this context, testing is not just about throughput—it is about precision, sensitivity, and confidence in every result.

Detection methods capable of measuring low endotoxin levels with confidence

• PYROSTAR ES-F: Endotoxin-specific detection

• PYROSTAR Neo+: Recombinant, low background, high sensitivity

Recombinant technologies and optimized workflows improve consistency

• PYROSTAR Neo+: Recombinant, low background, high sensitivity

Advanced detection approaches help manage complex viral matrices

• CMD αBET system: Overcomes interference in complex matrices

Minimize dilution requirements while maintaining assay performance

• PYROSTAR Neo+: Recombinant, low background, high sensitivity

Animal-free recombinant endotoxin detection reagents for high-sensitivity, endotoxin-specific assays

In vitro test that detects both endotoxin and non-endotoxin pyrogens

Rapid sterility testing solution delivering results in as little as seven hours

Fully integrated LAL testing system for rapid and sustainable endotoxin testing in under half the time as other methods