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Preclinical safety testing of biotechnology-derived pharmaceuticals

Understanding the issues and addressing the challenges

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Abstract

The unique and complex nature of biotechnology-derived pharmaceuticals has meant that it is often not possible to follow the conventional safety testing programs used for chemicals, and hence they are evaluated on a case-by-case basis. Nonclinical safety testing programs must be rationally designed with a strong scientific understanding of the product, including its method of manufacture, purity, sequence, structure, species specificity, pharmacological and immunological effects, and intended clinical use. This knowledge, coupled with a firm understanding of the regulatory requirements for particular product types, will ensure that the most sensitive and regulatory-compliant test systems are used to optimize the chances of gaining regulatory approval for clinical testing or marketing authorization in the shortest possible time frame.

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  1. Huntingdon Life Sciences, Woolley Rd, Alconbury, PE28 4HS, Huntingdon, Cambridgeshire, UK

    Frank R. Brennan

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  1. Frank R. Brennan
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Brennan, F.R., Shaw, L., Wing, M.G. et al. Preclinical safety testing of biotechnology-derived pharmaceuticals. Mol Biotechnol 27, 59–74 (2004). https://doi.org/10.1385/MB:27:1:59

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