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Immunogenicity of Protein Pharmaceuticals
Robert Dingman1, Sathy V Balu-Iyer1
1Department of Pharmaceutical Sciences, University at Buffalo, The State University of New York, Buffalo, New York 14214.
Abstract:
Protein therapeutics have drastically changed the landscape of treatment for many diseases by providing a regimen that is highly specific and lacks many off-target toxicities. The clinical utility of many therapeutic proteins has been undermined by the potential development of unwanted immune responses against the protein, limiting their efficacy and negatively impacting its safety profile. This review attempts to provide an overview of immunogenicity of therapeutic proteins, including immune mechanisms and factors influencing immunogenicity, impact of immunogenicity, preclinical screening methods, and strategies to mitigate immunogenicity.
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