FDA发布治疗性蛋白产品免疫原性检测抗药抗体分析方法开发与验证最终指南
Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection
FDA宣布发布最终指南《治疗性蛋白产品免疫原性检测——抗药抗体检测方法的开发与验证》，为临床试验中治疗性蛋白产品免疫原性评估的检测方法开发与验证提供建议。指南适用于抗药抗体（ADA）检测方法，也可能按个案适用于部分肽类、寡核苷酸和组合产品，涵盖筛查、确证、滴度和中和四类检测方法的开发与验证建议。该指南将2016年4月发布的修订版草案定稿并更改了标题，案卷编号为FDA-2009-D-0539。
这份最终指南由2016年4月草案定稿并更名，涵盖筛查、确证、滴度和中和四类抗药抗体检测方法的开发与验证建议。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2009-D-0539
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection.” This guidance provides recommendations to facilitate industry's development and validation of assays for assessment of the immunogenicity of therapeutic protein products during clinical trials. The guidance applies to assays for the detection of anti-drug antibodies (ADAs) and may also apply to some peptides, oligonucleotides, and combination products on a case-by-case basis. The guidance includes recommendations regarding the development and validation of screening assays, confirmatory assays, titration assays, and neutralization assays. This guidance finalizes the revised draft guidance for industry entitled “Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products” issued in April 2016 and includes a revised title.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2009-D-0539.
来源：FDA Pharmaceutical Quality Documents · fda.gov