---
title: "Respiratory Sensitization: Regulatory Problem: No Solution Until Now"
description: ALIsens® ofrece una solución innovadora y humana para la evaluación de la sensibilización respiratoria, ayudando a las industrias a cumplir con requisitos regulatorios y evitar fracasos costosos.
image: https://invitrolize.com/hubfs/Logo%20invitrolize%20HubSpot.jpg
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# Respiratory Sensitization: A Regulatory Problem with No Adequate Solution. Until Now.
Industry is expected to manage respiratory sensitization risk, yet lacks validated, human-relevant tools. ALIsens® changes this paradigm.
[Learn why](https://invitrolize.com/respiratory-sensitization-regulatory-problem-no-solution-until-now#3)
[Discover ALIsens®](https://invitrolize.com/alisens-in-vitro-lung-models-for-inhalation-safety)
## A Regulatory Gap with Real Consequences
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**.
 
### The Structural Problem
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.**
### [  A Critical Issue Regulatory scrutiny of inhalation exposure is increasing while animal testing is being restricted. Expectations are rising faster needing **more accurate, ethical, and efficient solutions**.](https://www.sprocketrocket.co/)
### [  The Consequences for Industry **Sensitization risks are detected too late,** leading to failed registrations, costly reformulations, delayed market access, and unnecessary loss of R&D investment.](https://www.sprocketrocket.co/)
### [  Why Existing Approaches Fall Short In vivo is scientifically limited,while current *in vitro* models focus on irritation or lack reproducibility. **None are designed to address respiratory sensitization.**](https://www.sprocketrocket.co/)
## The Regulatory Challenge in Respiratory Sensitization.
Respiratory sensitization is becoming a critical regulatory and industrial challenge, yet companies still lack practical, human-relevant tools to address it. In this video, our CEO explains why current approaches fall short and how ALIsens® changes what is possible in practice.
Video player - Lab1 compressed - Click to play video
## What ALIsens® Changes in Practice
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.
[](https://invitrolize.com/hs/cta/wi/redirect?encryptedPayload=AVxigLJC9W2S1zaJcK1QweqMf5RYO2bMp4DGiYkBxgwE5clgtJcRQakP6bPZET9LDBS8aJWt9%2Fq%2FhCiQCSoURKkd8cP6HwCY7ufpdjKhGJIHcvLCRs9NMaxzYbTkF5BLmEcjN8m356GvuHu8jmdhG7XnUj%2BhFbz4l4iqKWAAM8H2u34cb1JA2Qhr430yRVaoPv%2BhBRT2a1v3EKfAWTMIb4LQYIfYajh2Ymzmj%2BMDvCvuGXx5S9mqSsxfHBbwXcTDredFy173Iw%3D%3D&webInteractiveContentId=358790632672&portalId=25976007)
### Human-Relevant Biology
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®, the New Paradigm
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.**
### A Shift Driven by Regulatory Reality
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.
## Discover the Technology Behind ALIsens®
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.
[See How Industry Uses ALIsens®](https://invitrolize.com/regulatory-grade-respiratory-sensitization-for-industry)
## FOR CROs
Offer a high-value regulatory endpoint without developing the method yourself. ALIsens® enables CROs to expand their inhalation toxicology portfolio with respiratory sensitization testing designed for regulatory use.
- Add respiratory sensitization to your service offering.
- No multi-year assay development or validation.
- Regulatory-driven, OECD-aligned technology.
- Clear differentiation in tenders and client pitches.
- New high-margin revenue streams.
[Explore the CRO Partner Model](https://invitrolize.com/strengthen-your-cro-offering-with-invitrolize)
## FOR INDUSTRY
Identify respiratory sensitization risk early and generate human-relevant data trusted by regulators. ALIsens® helps industrial companies avoid late-stage failures, regulatory delays, and unnecessary R&D losses.
- Early identification of respiratory sensitizers.
- Differentiation between sensitizers and irritants.
- Human-relevant, animal-free data.
- Support for regulatory submissions.
- Reduced attrition and portfolio risk.
[See How Industry Uses ALIsens®](https://invitrolize.com/regulatory-grade-respiratory-sensitization-for-industry)
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