Evolving immunogenicity assay performance expectations and a lack of harmonized anti-drug antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving filing queries. Following debate at the American Association of Pharmaceutical Sciences National Biotechnology Conference, a group was formed to address these gaps. Over the last 3 years, 44 members from 29 organizations (including 5 members from Europe and 10 members from FDA) discussed gaps in understanding immunogenicity assay requirements and have developed harmonization tools for use by industry scientists to facilitate filings to health authorities. Herein, this team provides testing and reporting strategies and tools for the following assessments: (1) pre-study validation cut point; (2) in-study cut points, including procedures for applying cut points to mixed populations; (3) system suitability control criteria for in-study plate acceptance; (4) assay sensitivity, including the selection of an appropriate low positive control; (5) specificity, including drug and target tolerance; (6) sample stability that reflects sample storage and handling conditions; (7) assay selectivity to matrix components, including hemolytic, lipemic, and disease state matrices; (8) domain specificity for multi-domain therapeutics; (9) and minimum required dilution and extraction-based sample processing for titer reporting.

Heather Myler

João Pedras-Vasconcelos

Kelli Phillips

Charles Scott Hottenstein

Paul Chamberlain

Viswanath Devanaryan

Carol Gleason

Joanne Goodman

Marta Starcevic Manning

Shobha Purushothama

Susan Richards

Honglue Shen

Jad Zoghbi

Lakshmi Amaravadi

Troy Barger

Steven Bowen

Ronald R. Bowsher

Adrienne Clements-Egan

Dong Geng

Theresa J. Goletz

George R. Gunn

William Hallett

Michael E. Hodsdon

Brian M. Janelsins

Vibha Jawa

Szilard Kamondi

Susan Kirshner

Daniel Kramer

Meina Liang

Kathryn Lindley

Susana Liu

ZhenZhen Liu

Jim McNally

Alvydas Mikulskis

Robert Nelson

Mohsen Rajabi Ahbari

Qiang Qu

Jane Ruppel

Veerle Snoeck

An Song

Haoheng Yan

Mark Ware

The AAPS Journal

AAPS 杂志是美国药物科学家协会 (AAPS) 的官方期刊，发表了影响人类和兽医治疗的药物科学各个领域的新颖而重要的发现，包括：· 药物设计和发现· 制药生物技术· 生物制药、制剂, 和药物递送· 代谢和运输· 药代动力学、药效学和药效学· 转化研究· 临床评估和治疗结果· 监管科学我们邀请以下文章类型提交：· 原创研究文章· 评论和小型评论· 白皮书、评论, 和社论· 会议报告· 简要/技术报告和快速通信· 监管说明· 教程· 药物科学协议此外，AAPS 期刊还发布由客座编辑组织的主题，重点关注我们领域当前感兴趣的特定领域.

AAPS Journal is the official journal of the American Association of Pharmaceutical Scientists (AAPS), publishing novel and significant findings across various fields of pharmaceutical science that impact human and veterinary therapeutics. The main topics include: drug design and discovery, pharmaceutical biotechnology, biopharmaceuticals, formulation and drug delivery, metabolism and transport, pharmacokinetics, pharmacodynamics, translational research, clinical evaluation and therapeutic outcomes, and regulatory science. We invite submissions of the following article types: original research articles, reviews and mini-reviews, white papers, commentaries and editorials, conference reports, brief/technical reports and rapid communications, regulatory guidelines, tutorials, and pharmaceutical science protocols. Additionally, AAPS Journal publishes themed issues organized by guest editors, focusing on specific areas of current interest in our field.

AAPS Journal 是美国药物科学家协会 (AAPS) 的官方期刊，发表影响人类和兽医治疗的药物科学各个领域的新颖而重要的发现。主要涵盖以下主题：药物设计与发现、制药生物技术、生物制药、制剂与药物递送、代谢与运输、药代动力学、药效学、转化研究、临床评估与治疗结果以及监管科学。我们欢迎以下类型的文章提交：原创研究文章、评论与小型评论、白皮书、评论与社论、会议报告、简要/技术报告与快速通信、监管说明、教程及药物科学协议。此外，AAPS Journal 还发布由客座编辑组织的主题，重点关注我们领域当前感兴趣的特定领域。

AAPS Journal

Anti-drug Antibody Validation Testing and Reporting Harmonization

This team provides testing and reporting strategies and tools for the following assessments: pre-study validation cut point, system suitability control criteria for in-study plate acceptance, and domain specificity for multi-domain therapeutics.

抗药物抗体验证检测与报告标准化

Category	Quartile
医学	3
医学, 药学	3

Anti-drug Antibody Validation Testing and Reporting Harmonization

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Journal Info

Category	Quartile
PHARMACOLOGY & PHARMACY	1