Tests to determine or confirm product identity are core both throughout product development and market supply phases. The use of compendial analytical methods where applicable, or phase appropriate validation according to ICH guidelines where needed, ensures compliance and helps to secure regulatory approval. At Eurofins BioPharma Product Testing Netherlands we collaborate with customer scientists to develop the required testing portfolio to characterize raw materials, excipients, API, formulated product, and stability over time.
Whereas identity testing for small molecules heavily relies on physico-chemical techniques, testing of biologicals uses a more diverse array of approaches. Still, ICH-Q6B stipulates that identity testing needs to unequivocally demonstrate the presence of active compound or principle, and more than one type of test may be required to do so. These tests depend on product type, which may range from peptide, (modified) protein, nucleic acid, all the way to populations of (altered) cells in cellular therapies. Product conform tests need to be established or adapted from discovery, a road that is traveled frequently and with success. Eurofins scientists will prove to be the reliable partner in establishing the right array of tests.
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Why choose Eurofins BioPharma Product Testing
- All services available internally. As Eurofins BioPharma Product Testing Netherlands has several complementary companies, all this expertise is brought together in one multidisciplinary organization.
- Standard and custom solutions. If our standard solutions do not fulfill your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.