Cell therapy products present unique challenges for pyrogen and sterility testing. Unlike traditional biologics, these therapies involve complex matrices that may include cells, proteins, and media components—each of which can interfere with conventional assays.

Key challenges include:

• Assay interference from biological components
• Limited sample availability
• Risk of false positives or inhibition
• Increasing demand for rapid release timelines

These factors require testing strategies specifically designed for complex biological environments.

Endotoxin-specific reagents help reduce false positives and improve confidence in results

• PYROSTAR ES-F: Endotoxin-specific detection

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

Advanced detection approaches mitigate the impact of complex sample components

• CMD αBET system: Overcomes interference in complex matrices

Solutions compatible with compendial methods and evolving guidelines

• Global Pharmacopoeia Harmonization for Modern Pyrogen and Endotoxin Testing

Rapid sterility testing options help reduce time to release

• RiboNAT Rapid Sterility Test: Reduces release delays compared to traditional sterility testing

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