Non-animal alveolar in vitro model for toxicity analysis

The industry expects respiratory testing to become mandatory around 2028. If you have many compounds to analyse, it is best to start as soon as possible.
If a harmful compound is found in a product, it will be automatically withdrawn from the market, wiping out the investment in R&D and marketing.
You may accept the "loss" of certain molecules BUT we are sure you will want to avoid this happening to your new replacements, right?

Pharma

Inhalable drugs - hazard assessment very early in drug candidate identification.

Cosmetics

Many of these products are sprayed and then inhaled - so nothing to worry about?

Chemical Industry

Concerned to find out in some years that new products have hazardous properties?

Food

What happens after inhalation of foodborn proteins and other allergens?

Environment

Citizens are exposed to many chemicals and (nano)particles indoor and outdoor - and all is safe?

Consumer products

Sure that your customers are not inhaling anything hazardous?

Manufacturing

Are your workers exposed to inhalable chemicals or particles and are you aware about the hazard?

Crop protection

What is the hazard of sprayed new chemicals upon inhalation for farmers or operators during its production?

Tobacco

Wondering about sensitzing potential of new ingredients or products?

What is the sensitivity, specificity and accuracy for the sensitization and irritation models?

ALIsens is a young technology but has currently identified all tested chemicals correctly. The model correctly identified the pro-haptens, Ethylenediamine and Piperazine as respiratory sensitizers, chemicals which have been reported as false negative in other assays. It is clear to us that sooner or later any test will provide false positive and false negative results and we will report such limitations immediately here.
How robust is the model?

Data obtained by different operators show that given proper training results obtained by different persons are comparable. The models have been shipped to academic institutions within various research projects and data obtained after shipment have been shown to be identical to the ones obtained in our premiss.
How can I apply the results to hazard identification?

The obtained results will give you information on the hazard that a certain tested chemical has the potential to induce respiratory sensitization. We are currently working to see whether a potency assessment is possible. The results can guide your product development to select molecules with lower hazard.
How can I apply the results to an operator/ consumer/ patient risk assessment?

The test results will give you an indication of the hazard that a certain compound has the potential to induce respiratory sensitization or is irritating to the alveolar region of the lung.
Can ALIsens be used for other applications e.g. fibrotic potential or new drugs for lung fibrosis?

We are currently exploring the possibilities to detect early markers of fibrosis and efficacy of drugs for the treatment of fibrosis in our models together with an academic partner. In case you are interested in this question, please contact us to discuss further details of our progress or how you can be involved in development projects.
Who are the CRO partners and how can I contact them?

We are currently in discussion with CROs on adding ALIsens to their portfolio. We are also happy to discuss this with the CRO of your choice. If you are interested in partnering us to offer the ALIsens model for lung sensitization and irritation, please contact us.
How long does the assay take from receipt of test item to sharing the results with me?

Usually, the pre-screening and final testing including the necessary technical and biological replicates can be done with 4-6 weeks/ chemical. The schedule will be communicated to you as this will be based on the number of chemicals to be tested.
Are there other models that can be run in parallel as a testing battery?

ALIsens inserts can be exposed in parallel with primary cell-based models for the airways commercially available. Results of these models can also be evaluated together in a holistic approach considering that some models are based on primary cells while ALIsens is based on cell lines.
When will this model enter formal validation and when should we expect this to be completed?

ALIsens has been submitted to EURL ECVAM in August 2019. In November 2020, we received the notification of the pre-submission outcome following PARERE consultation and were invited to submit a revised version. An eventual submission to OECD is envisaged for 2023.
Are there plans for IATA or OECD test guidelines?

In 2022 a few countries submitted a standard project submission form (SPSF) to the OECD proposing a detailed review paper on respiratory sensitization. An eventual submission of the SPSF for a test guideline on respiratory sensitization to OECD is envisaged for 2023 or 2024.

Early detection of harmful respiratory compounds.

They Trust Us

Avoid these problems with us:

Discover ALIsens...

... the only in vitro model capable of identifying respiratory sensitisers and distinguishing them from irritants early in product development.

What they say about us

Applications of our alveolar model for hazard assessment