Technology development of immunogenicity assessment for biopharmaceuticals
10.7501/j.issn.1674-6376.2017.07.025
- VernacularTitle:生物技术药物免疫原性评价的技术发展概述
- Author:
Ying HUANG
1
;
Hua JIANG
;
lu Lu LI
;
Wei LI
;
Xin WANG
;
Yan HUO
Author Information
1. 中国食品药品检定研究院国家药物安全评价监测中心
- Keywords:
biotechnology;
drug evaluation;
immunogenicity;
safety evaluation;
assessment of immunogenicity
- From:
Drug Evaluation Research
2017;40(7):999-1004
- CountryChina
- 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.
