Immunotoxicology testing of monoclonal antibodies in macaca fascicularis

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TypeBook Chapter
Book titleThe Nonhuman Primate in Nonclinical Drug Development and Safety Assessment
Subjectnonhuman primate; monoclonal antibodies; immunotoxicology; developmental immunotoxicology
AbstractMany therapeutic monoclonal antibodies (mAbs) are in development for a wide array of indications. Because of the nature of the product and/or the intended pharmacology, mAbs are assessed for their potential immunomodulation, whether intended or not. Immunomodulation and immunotoxicology (i.e., immunosuppression, immunogenicity, immunostimulation) can be related. The intended immunomodulatory effect of mAbs is the intended pharmacology for clinical efficacy. Exaggerated or prolonged pharmacological activity may, however, result in adverse immunomodulation, leading to unpredictable and unintended immunotoxicology outcomes. Nonhuman primates (NHPs) are often considered as the most relevant species to perform preclinical studies for the testing of mAb-induced immunomodulation and immunotoxicity. This chapter focuses on regulatory considerations associated with the testing of mAbs in NHPs, the mAb product and biomanufacturing process characteristics to take into consideration for immunogenicity testing, and the preclinical study designs in adult and juvenile NHPs to monitor immunomodulation.
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AffiliationHuman Health Therapeutics; National Research Council Canada
Peer reviewedYes
NPARC number23001502
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Record identifier8df9fc4b-7aa4-4701-903a-43f43d503d70
Record created2017-02-20
Record modified2017-02-20
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