Immunogenicity risks

Kropshofer H. Preclinical immunogenicity risk assessment of biotherapeutic proteins. In Weinbauer G, Vogel F, eds. Novel Approaches towards Primate Toxicology. Muenster Waxmann, 2006 91-102. 

These impurities pose risks for the safety of proteins used as therapeutics and must be removed to a final concentration below their target limit. In addition, the product stream contacts materials such as filters and resins. Extractables, such as leachates from protein A resins, can pose an immunogenic risk to the patient and must be eliminated.75 Finally, adventitious agents such as viruses and bacterial pathogens or related contaminants such as endotoxins can lead to serious problems with the safety of the protein preparation and therefore must be minimized. Table 32.6 lists concentrations for the above impurities that are generally considered acceptable in a final protein product.76... 

Figure 10.3-4 Differences in the gene frequency of prominent HLA-DRBl allotypes in the Caucasian (black) versus Japanese (blue) population. As particular DRBl alleles may confer increased immunogenicity risk for a particular drug, the incidence of immu-nogenicity of a particular drug may vary widely in patient populations of different ethnic groups.

Early stage attempts of assessing immunogenicity risks will not only improve our immunogenicity prediction capabilities but also release the burden from... 

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