Biotechnology Derived Proteins

Most products derived by biotechnology will be immunogenic in animals. Therefore, the FDA requires measurement of antibodies directed toward the biotechnology-derived product, usually as an endpoint in repeat dose toxicity studies. For regulatory purposes, the appearance of antibodies is correlated with changes in the pharmacokinetic or pharmacodynamic parameters of the test compound. These data allow antibody classification as either neutralizing or nonneutralizing.

The antibody response is considered insignificant when certain criteria are fulfilled. The criteria are (1) there is no dose-related immune response to the biotechnology-derived product, (2) the response is variable and occurs in only a small number of test animals, and (3) pharmacological or toxicological effects occur only in a small number of animals.

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