Test protocols such as the OECD test guidelines and standard methods like ET50 for skin irritancy are great for assessing products for regulatory submission. We often find though, when it comes to candidate selection, claims substantiation and benchmarking, clients want to dig a little deeper. This is when you should consider bespoke testing…

How can we adapt tests to make them bespoke to you?

We have adapted many test methods for our clients so that they can really hone in on the information they need for safe and successful product development. We have helped to tease out the smallest of differences in mildness of formulations and set up experiments which replicate real-life exposure to the products being tested. When you read through our examples you may find yourself thinking about your own testing regimes and how they can be further adapted to really give you the data you need. And if a test method doesn’t exist, we can even advise on the best strategy to fill that gap.

Scenario 1: Range-finding and refining for detailed response studies

A client wanted to investigate the effect their test item had on viability and gene expression. There were a lot of unknowns about the item, and we needed to identify a specific window where we would see the responses. We performed an initial experiment (a range-finding experiment) with fairly broad time points to identify where the response appeared (i.e. where we saw gene expression occurring, and viability hadn’t been knocked down too low). In a second experiment we were then able to refine the time points to within this window and gain much more detail about what was happening.

Scenario 2: Assessing positive impact of a product

To investigate oral care product efficacy, we developed a study which challenged gingival tissue with a bacterial irritant, followed by repeated application of an oral care active to mimic an average oral care routine. Various endpoints (tissue viability, barrier integrity, cell markers, tissue morphology) used to report on efficacy of the active involving a new test system, customised time points, and specific requirements for the reporting of data. Similar projects have taken place with skin mildness, and small intestine viability.

Scenario 3: Investigating alternative endpoints

Most standard studies using reconstructed tissue models only look at viability as an endpoint e.g. skin ET50 looks at tissue viability and uses it to classify the level of irritancy/mildness. Some clients want a more in-depth picture of what’s going on in the tissues, either to provide further evidence of skin mildness, or maybe to investigate another endpoint in parallel. An example is the extraction of mRNA from the tissues which lets us conduct PCR, and check for markers which may be related to an inflammatory response. Similarly, using the conditioned medium, the proteins excreted by the tissue models could be used in an ELISA to look for inflammation (or many other endpoints of interest).

Want to see how we can help you bridge your testing gap? Get in touch with us today and find out more about our bespoke testing.

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