Yes we are. Our Good Laboratory Practice (GLP) accreditation by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency) means that we can provide you with in vitro safety test data that can be used for compliance with a wide range of European and global regulations.
The place to start is to establish if you need the test results as part of a regulatory submission, or whether you want to discover a substance’s properties as part of a product development or pre-clinical programme. We’re always happy to advise before you start so please feel free to call if you’re unsure.
We don’t provide the Ames test, as it uses animal components. We do provide the BlueScreen assay, a genotoxicity test that covers all types of genotoxicity: anugens, clastogens, and mutagens.
This request only applies to the DPRA test. If you aren’t able to provide the molecular weight, you can detail the list of constituents with percentage compositions and we can approximate it using the guidance in the Test Guideline. As a last resort, the test item may be run neat (liquids) or dissolved at the highest soluble concentration (solids) then combined at a 1:10 or 1:50 ratio using the Cysteine and Lysine containing peptides respectively.
Noting the purity of the item being tested is part of our GLP (Good Laboratory Practice) compliance. For certain tests, it allows us to ensure the correct concentration is being tested. It’s also another piece of key information that we check to make sure we have the right test item, and you get the right result.
No, we don’t but many clients use our in vitro tests as an early screen in product development before they get to more expensive human trials. They can also be used to generate supporting information in a weight-of-evidence approach to safety assessment. XCellR8’s tests may give you a binary classification on the effect of an ingredient, for example, Irritant or Non Irritant, or a more detailed classification to help you rank irritation potential. Please get in touch if you’d like to find out more.