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.
Integrate ALIsens® into your service portfolio and deliver human-relevant, regulator-trusted respiratory sensitization data to your clients.
Respiratory sensitization is a critical but largely unaddressed toxicological endpoint. No validated in vitro methods exist today, while regulatory pressure is increasing and industrial clients are actively requesting reliable, human-relevant data.
ALIsens® was developed specifically for regulatory use. It is based on immortalized human cell lines, aligned with OECD requirements, and is actively progressing through the OECD standardisation pathway for future regulatory acceptance.
Most CROs offer irritation or general inhalation toxicology. Very few can address respiratory sensitization. Today, only one in vitro model is technically designed to reach OECD acceptance, creating a clear differentiation opportunity.
Working with Invitrolize allows CROs to enhance their respiratory toxicology capabilities without increasing internal complexity. Our in vitro models support earlier risk identification, reduce uncertainty for clients, and reinforce your position as a scientifically advanced partner.
The result is stronger client confidence, differentiated services, and improved support for regulatory-facing projects.
Respiratory sensitization is moving from a scientific gap to a regulatory requirement. ALIsens® was designed from the outset for regulatory applicability, using immortalized human cell lines and reproducible endpoints compatible with OECD expectations. The model is progressing toward OECD standardization, positioning CROs to respond early to upcoming REACH, ECHA, EPA, regulatory-driven demands rather than reacting once requirements become mandatory.
Before onboarding, invitrolize performs a structured technical assessment to confirm that the CRO can reproduce ALIsens® data at regulatory grade.
Together with your team, we define:
Cell culture infrastructure and quality systems.
ALI exposure capabilities (e.g. Vitrocell® or equivalent).
Biosafety level and handling procedures.
Experience with immunological and molecular endpoints.
Data integrity and reporting workflowsThe nature of the compound or formulation.
This step prevents downstream variability and protects regulatory credibility.
Once validated, invitrolize delivers hands-on, method-specific training to the CRO’s scientific staff.
The training includes:
ALIsens® model biology and scientific rationale.
Insert handling and preparation.
ALI exposure protocols for different compound classes.
Endpoint selection and interpretation.
Common failure modes and quality controlshuman respiratory cells to the test compound.
The training is delivered by the original developers of the model.
The CRO executes a predefined set of verification runs using reference compounds.
Objectives:
Confirm inter-lab reproducibility.
Validate signal discrimination between sensitizers and irritants.
Ensure correct execution of exposure and readoutsA comprehensive scientific report.
All results are reviewed jointly with invitrolize. By this, you will get a formal confirmation you can generate data equivalent to invitrolize’s internal benchmarks.
After successful verification, the CRO is formally authorized to offer ALIsens® testing services.
Partner status includes:
The CRO retains full ownership of client relationships and reporting.
Invitrolize provides an exciting opportunity to assess challenging chemicals for challenging endpoints in respiratory toxicity with human-relevant approaches. They are grounded in science while having a clear view of regulatory application to advance toxicology, and we are excited to work with them.
Kristie Sullivan, MPH, Vice President for Research Policy
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.
