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Hervé Lebrec, Padma Narayanan and Raymond Nims Overview of the nonclinical quality and toxicology testing for recombinant biopharmaceuticals produced in mammalian cells Journal of Applied Toxicology 30

Version of Record online: 29 JUN 2010 | DOI: 10.1002/jat.1551

There are differences in the overall safety (quality and toxicology) testing paradigms for small molecules and biopharmaceuticals. These differences are consequences of both the manufacturing processes involved and the nature of the molecules themselves. Strategies for nonclinical toxicology testing of biopharmaceuticals differ from the paradigms used for small molecules and need to be defined on a case-by-case basis, taking into consideration species cross-reactivity of the molecule of interest. This manuscript reviews the quality and nonclinical toxicology testing for mammalian-cell-derived products.

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