Research and development

ANIMAL PRODUCT-FREE SAFETY TESTING

Many in vitro testing methods use animal-derived components such as serum, trypsin, tissue extracts and antibodies. In our view, this casts doubt on whether these methods can truly be called animal-free.

In comparison, XCellR8 is the only contract testing laboratory globally that does not use any animal-derived products – we never have and we never will. We develop new test methods using completely animal product-free conditions from the outset. We also adapt existing methods to animal product-free conditions, and seek regulatory approval for the adaptations, ensuring that the data generated can be used by our clients in regulatory submissions.

In 2017, we were delighted to gain approval for our animal product-free adaptation of the KeratinoSens™ skin sensitisation test to be included onto OECD Test Guideline 442d.

FURTHER READING

POSTER: Adaptation of human cell based safety tests to animal product-free conditions

POSTER: Use of 3 animal product-free methods as part of a novel integrated approach to skin sensitisation testing

SHORT COMMUNICATION: Adaptation of the KeratinoSens™ skin sensitisation test to animal product-free cell culture

ACUTE SYSTEMIC TOXICITY

Acute systemic toxicity is the only human health endpoint in Annex VII of REACH that has no non-animal test available. There are currently no new in vitro methods in validation, but we aim to change that.

With funding from Innovate UK from 2014-2016, we took the first steps by developing a non-regulatory screen for human acute toxicity, using human cells in animal product-free culture. The screen was internally validated for cosmetic ingredients and is already used by our clients a part of a weight-of-evidence approach in REACH submissions, to avoid the widely discredited LD50-related animal tests.

Now with support from the European Horizon 2020 programme, we are planning to further develop the test and expand its applicability across a range of chemical sectors, as well as seeking regulatory approval for the screen to eventually be used as part of a non-animal testing strategy for human acute toxicity.

FURTHER READING

COMMENT: Non-animal replacements for acute toxicity testing

POSTER: Development of an animal product-free acute toxicity screen

 

COSMETIC SAFETY AND EFFICACY

Supported by funding from Innovate UK, in Autumn 2017 we started a collaborative project with Cutest, a Cardiff-based dermatological testing laboratory, looking at correlations between human in vitro / in vivo tests for consumer product safety.

We are working closely with cosmetic companies to evaluate a range of ingredients using in vitro human skin models, while Cutest will carry out parallel studies using human volunteers. In the process, we’ll be able to optimise methods for measuring skin irritation caused by single and repeat dosing, and to assess how well the in vitro models correlate directly with human studies.

This is a great advancement over historical approaches in which in vitro tests have been validated and benchmarked against animal data, which often gives a poor prediction of human responses.

FURTHER READING

PRESS RELEASE: XCellR8 & Cutest project

If you’d like to learn more about research and development projects we’re working on now, or are hoping to start in the future, get in touch today.