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ALIsens® — In Vitro Lung Models for Inhalation Safety

Human-relevant respiratory safety testing

Identify irritation and respiratory sensitization risks early, under realistic air–liquid interface exposure.

ALIsens®: an in vitro platform to identify respiratory sensitizers.

 

ALIsens® is a patented 3D in vitro alveolar lung model that recreates the human alveolar–capillary barrier under air–liquid interface (ALI) conditions. By combining human epithelial, endothelial, and immune cell lines in a structured architecture, the model enables realistic exposure of inhalable substances such as aerosols, vapors, and particulates.

ALIsens® fits seamlessly into early R&D decision-making, hazard identification, and regulatory-oriented safety packages. It supports compound prioritization, formulation optimization, and the generation of robust data aligned with evolving regulatory expectations, including REACH and OECD-driven frameworks.

 

How ALISens works

Turning respiratory biology into actionable evidence

ALIsens® combines human lung and immune cell lines in a structured 3D architecture that mimics the alveolar–capillary barrier. Test substances are delivered under controlled air–liquid interface conditions, replicating real inhalation exposure and enabling precise assessment of irritation and sensitization responses.

The Problems ALIsens® Solves

From start-to-finish, the design and strategy team provide all of the guidance and expertise necessary to build a high-conversion website.

Strengthen Regulatory Submissions

Generate human-relevant, mechanistically informed data designed to support regulatory dossiers as respiratory sensitization moves toward formal requirements.

Prevent Late-Stage Failures

Identify problematic compounds early and reduce attrition by detecting respiratory hazards before significant R&D and scale-up investments are made.

Reduce Reputational and Recall Risk

Detect irritation or sensitization liabilities early in development, minimizing the risk of post-market withdrawals, litigation, or brand damage.

Avoid Animal
Testing

Access a human cell–based alternative aligned with animal testing bans, internal policies, and ethical commitments, without compromising scientific relevance.

Multiple applications, one human-relevant approach.

ALIsens® Irritation Model

The irritation model is the most streamlined configuration of ALIsens®, designed for rapid assessment of local respiratory effects. It focuses on early inflammatory and cytotoxic responses following realistic inhalation exposure. This variant is typically used for screening, formulation comparison, and dose-ranging studies where fast, reliable irritation data are required to guide early development decisions.

  • Ideal for early-stage hazard flagging and compound ranking

  • Shorter timelines and lower complexity

  • Clear indication of irritation potential under ALI conditions

Lab1 compressed

Advanced in vitro science meets regulatory relevance

+60%

of regulatory delays are linked to data gaps or requests for additional safety evidence.
ALIsens vs Human in vivo data

ALIsens® vs Human in vivo data

Chemical irritants vs sensitizers
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Real-world performance and validation evidence

ALIsens® correctly identifies respiratory sensitizers (e.g., phthalic anhydride, trimellitic anhydride) and distinguishes them from irritants (e.g., acrolein) by analysing biomarker expression patterns under controlled ALI exposure.

This capability has been highlighted in independent research showing that ALIsens® can successfully discriminate respiratory sensitizers from skin sensitizers and non-sensitizers — a key challenge for traditional assays.

Explore our case studies

DESIGNED FOR

ALIsens® supports a range of scientific and regulatory end users

CRO's

Expand respiratory toxicology capabilities y generate human-relevant evidence for client submissions.

Industry

De-risk compounds early in development and support regulatory safety assessments for chemicals, pharma, cosmetics and consumer products.

Academia & Research

Advance understanding of respiratory sensitization mechanisms and validate new markers and models in inhalation toxicology