Scholarlink

<p>The anti-drug antibody validation testing and reporting harmonization (ADAH) white paper was published December 2021 and has generated significant interest, highlighting its utility within the scientific community. Following the ADAH white paper, members of the American Association of Pharmaceutical Scientist (AAPS) Therapeutic Product Immunogenicity community published a similar white paper addressing neutralizing antibody validation testing and reporting harmonization (NAbH) in July 2023 which has also been broadly accessed. Given the broad interest in these white papers by the bioanalytical and immunogenicity communities, the authors have solicited user feedback to address noted gaps. This feedback has prompted us to issue an addendum to address these gaps including adding a section on anti drug antibody (ADA) assay cross-validation and ADA data presentation for regulatory submissions, and to update the method sensitivity assessments. In addition, given recent year discussions around the implementation of signal to noise over titer, a section on this topic is included.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Anti-drug Antibody Validation Testing and Reporting Harmonization Addendum

  • 期刊论文

  • 发表日期：

    2026年1月8日

查看全文
  • Heather Myler,
  • Johanna Mora,
  • Joao Pedras-Vasconcelos,
  • Amy Lavelle,
  • Paul Chamberlain,
  • Luying Pan,
  • LiLi Yang,
  • Daniel Kramer

摘要

The anti-drug antibody validation testing and reporting harmonization (ADAH) white paper was published December 2021 and has generated significant interest, highlighting its utility within the scientific community. Following the ADAH white paper, members of the American Association of Pharmaceutical Scientist (AAPS) Therapeutic Product Immunogenicity community published a similar white paper addressing neutralizing antibody validation testing and reporting harmonization (NAbH) in July 2023 which has also been broadly accessed. Given the broad interest in these white papers by the bioanalytical and immunogenicity communities, the authors have solicited user feedback to address noted gaps. This feedback has prompted us to issue an addendum to address these gaps including adding a section on anti drug antibody (ADA) assay cross-validation and ADA data presentation for regulatory submissions, and to update the method sensitivity assessments. In addition, given recent year discussions around the implementation of signal to noise over titer, a section on this topic is included.