藥物的免疫原性是指藥物刺激機(jī)體形成特異抗體或致敏淋巴細(xì)胞的性質(zhì)。評(píng)價(jià)非期望的免疫原性是生物技術(shù)藥物臨床前和臨床評(píng)價(jià)的重要內(nèi)容。免疫原性評(píng)價(jià)內(nèi)容包括方法的開(kāi)發(fā)、驗(yàn)證、藥物誘導(dǎo)的抗體反應(yīng)水平檢測(cè)（滴度）、抗體的特性研究、抗體的中和活性測(cè)定、分析抗體產(chǎn)生對(duì)療效、毒性和藥動(dòng)學(xué)的影響，并預(yù)測(cè)對(duì)人體潛在的免疫原性強(qiáng)弱。如何提高動(dòng)物模型的預(yù)測(cè)性、優(yōu)化檢測(cè)技術(shù)、實(shí)現(xiàn)評(píng)價(jià)方法的規(guī)范化和標(biāo)準(zhǔn)化，是未來(lái)免疫原性評(píng)價(jià)亟需解決的問(wèn)題。

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.

十二五國(guó)家科技重大專項(xiàng)（2015ZX09501007-004）；中國(guó)食品藥品檢定研究院中青年發(fā)展研究基金（2014C5）