Respiratory sensitization is increasingly scrutinized and expected to become a formal regulatory requirement. Yet industry still lacks validated, human-relevant tools to address this endpoint with confidence.
Respiratory sensitization is a recognized health and regulatory concern, yet no validated in vitro method exists to address it. And industry is expected to manage it with no delays.
Until now, industry has relied on animal models or simplified in vitro systems that fail to capture the biological mechanisms driving respiratory sensitization. These approaches were never designed to support regulatory decision-making for this endpoint.
What ALIsens® enables in practice:
Direct identification of respiratory sensitizers and clear differentiation from irritants.
Human-relevant, animal-free data generated under realistic exposure conditions.
Reproducible results suitable for inter-laboratory use and regulatory review.
Alignment with current and upcoming regulatory requirements.
Current approaches rely on irritation, inflammation, or animal data as surrogates for respiratory sensitization, failing to reflect the human immune mechanisms that drive allergic responses in the lung.
Animal models are increasingly restricted and poorly predictive for human respiratory outcomes, leaving industry without acceptable tools for sensitization assessment.
And other in vitro lung models focus on general toxicity or irritation and are not designed to address immune-mediated respiratory sensitization.
ALIsens® directly reproduces the human alveolar barrier in a 3D air–liquid interface system, enabling assessment of respiratory sensitization under realistic inhalation exposure conditions.
The model differentiates respiratory sensitizers from irritants, allowing earlier and more reliable safety decisions during product development.
Human-relevant, animal-free data can be generated before major R&D or regulatory commitments are made.
ALIsens® was designed specifically for regulatory applicability, with reproducibility and inter-laboratory transfer as core design criteria.
The model is based on immortalized human cell lines, aligning with OECD requirements and enabling future standardisation.
Respiratory sensitization is expected to become a regulatory requirement, making early adoption of regulatory-ready methods a strategic advantage.
Learn how ALIsens® reproduces the human alveolar barrier under realistic exposure conditions and enables regulatory-grade identification of respiratory sensitizers using a patented, human-relevant in vitro model.
