Biopharmaceuticals carcinogenicity testing

May be only feasible approach if no usable species responding to the clinical biopharmaceutical is available (e.g., no terminable studies feasible in chimpanzees, carcinogenicity testing not feasible in NHPs)... 

In addition, tests for mutagenicity and carcinogenicity are not likely required for most biopharma-ceutical substances. The regulatory guidelines and industrial practices relating to biopharmaceuti-cal preclinical trials thus remain in an evolutionary mode, and each product is taken on a case-by-case basis. An overview of the main preclinical tests undertaken for a sample biopharmaceutical... 

Note 3 With some biopharmaceuticals there is a potential concern about accumulation of spontaneously mutated cells (e.g., via facilitating a selective advantage of proliferation) leading to carcinogenicity. The standard battery of genotoxicity tests is not designed to detect these conditions. Alternative in vitro or in vivo models to address such concerns may have to be developed and evaluated. 

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