Immunotoxicity, Immunogenicity and Immunopharmacology of Therapeutic Proteins, by J. L. Bussiere; P1208.1104

Introduction Immunotoxicity testing for biotechnology products such as human proteins and monoclonal antibodies is often conducted in nonhuman primates. These human proteins may not be pharmacologically active in rodents or may be immunogenic, such that rodents would develop neutralizing antibodies to the drug. These don’t appear to be very significant points!!! There are certain advantages to using nonhuman primates for immuntoxicity testing in that blood volume is not as limited as in rodents and many of the immune tests in nonhuman primates can then be used in the clinical trials. The major disadvantage of nonhuman primates is that animal numbers are limited and the variability is large; similar to the variability seen in humans. Many of the standard immunotoxicity tests are not well characterized in the nonhuman primate and further development of these assays is needed. The cynomolgus or rhesus macaque is the most common nonhuman primate species used in toxicology studies and are currently the most used species for immunotoxicity testing. Marmosets may also be useful in immunotoxicity testing and have an advantage due to their small size, although the historical database is not as extensive for this species. Some human proteins are only pharmacologically active in chimpanzees and although immune testing can be done in this species, the number of animals is so small that they are unlikely to provide much useful information.