Drug Evaluation Research 2017;40(7):999-1004

doi:10.7501/j.issn.1674-6376.2017.07.025

Technology development of immunogenicity assessment for biopharmaceuticals

Ying HUANG 1 ; Hua JIANG ; lu Lu LI ; Wei LI ; Xin WANG ; Yan HUO

Affiliations

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Keywords

biotechnology; drug evaluation; immunogenicity; safety evaluation; assessment of immunogenicity

Country

China

Language

Chinese

Abstract

The unwanted immunogenicity of biopharmaceutical is an adverse reaction caused by long-term medication.The primary concerns of immunogenicity would be critical for the efficacy and safety of biopharmaceutical.The immunogenicity assessments include validation of methodology,detection of anti-drug antibodies,characterization antibodies and their subtypes against biopharmaceuticals,determination of antibody neutralization as well as the analyses of relationship of antibody formation to pharmacokinetics and pharmacodynamics parameter and toxicities of drugs.The optimization of detection methods,the predictability of immunogenicity with available animal models and the standardization of evaluation method are currently the major challenges in the assessment of immunogenicity for biopharmaceuticals.