Biopharmaceuticals immunotoxicity testing

General Toxicity Testing and Immunotoxicity Testing for Biopharmaceuticals... 

Immunotoxicity testing as outlined in the ICH S8 document [4] is not intended to cover biopharmaceuticals. However, many of the same assays can be used to assess immunologic effects of biopharmaceuticals [5,6], These assays can help assess immunopharmacology as well as potential immunotoxicity as discussed later in this chapter. 

Immunotoxicity testing guidelines exist for small molecules where the toxicology is largely unpredictable and rodent species are typically used [4]. Despite the lack of a specific guidance on immunotoxicity evaluation until now, most biopharmaceuticals have assessed the immunotoxic potential of the biophar-maceutical as a part of general single- and/or repeat-dose toxicity studies [5,23]. 

Immunotoxicity testing in various animal models is common for biologies because of their immunomodulatory nature. Since most biopharmaceuticals... 

Immunotoxicity testing of biopharmaceuticals can be very challenging, since rarely can the clinical drug candidate be tested in the standard rodent models. These assays are either conducted (when appropriate) in NHPs or in a rodent with a surrogate molecule, or in a rodent with the target knocked-out or overexpressed. All of these options have their own issues and caveats which pres-... 

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