.png){kind=icon}
返回
Neutralizing Antibody Validation Testing and Reporting Harmonization
.png){kind=icon}
OA
AI
DOI：10.1208/s12248-023-00830-5.png)
.png){kind=icon}
原文求助.png){kind=icon}
分享.png){kind=icon}
收藏
摘要
En 中文
Evolving immunogenicity assay performance expectations and a lack of harmonized neutralizing antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving filing queries. A team of experts within the American Association of Pharmaceutical Scientists' Therapeutic Product Immunogenicity Community across industry and the Food and Drug Administration addressed challenges unique to cell-based and non-cell-based neutralizing antibody assays. Harmonization of validation expectations and data reporting will facilitate filings to health authorities and are described in this manuscript. This team provides validation testing and reporting strategies and tools for the following assessments: (1) format selection; (2) cut point; (3) assay acceptance criteria; (4) control precision; (5) sensitivity including positive control selection and performance tracking; (6) negative control selection; (7) selectivity/specificity including matrix interference, hemolysis, lipemia, bilirubin, concomitant medications, and structurally similar analytes; (8) drug tolerance; (9) target tolerance; (10) sample stability; and (11) assay robustness.
Keyword:
anti-drug antibodies (ADA)
FDA
immunogenicity
neutralizing antibodies (NAb)
regulatory guidance
validation
期刊
IF:
3.7
论文数:
2.3K
被引数:
7.5K
机构
查看更多机构
引用论文
The Impact of the CHILE Intervention on the Food Served in Head Start Centers in Rural New MexicoOAAI
OAAI分享收藏Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides-Harmonized Terminology and Tactical Recommendations.png)
AAPS JOURNALOAAI
AAPS JOURNALIF3.7
OAAI分享收藏
分享收藏分享收藏Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target PopulationAAPS JOURNAL
AAPS JOURNALIF3.7
PREAI
分享收藏分享收藏 查看更多内容