Recommendations for the development and validation of confirmatory anti-drug antibody assays

Author:

Jani Darshana1,Marsden Robin2,Mikulskis Alvydas3,Gleason Carol4,Klem Thomas5,Krinos Fiorotti Corinna1,Myler Heather4,Yang Lin6,Fiscella Michele6

Affiliation:

1. Pfizer Inc., One Burtt Road, Andover, MA 01810, USA

2. La Jolla Pharmaceutical Company, 10182 Telesis Court, 6th Floor, San Diego, CA 92121, USA

3. Biogen Idec, Inc., 125 Broadway, Boston, MA 02142, USA

4. Bristol-Myers Squibb, Route 206 & Province Line Road, Princeton, NJ 08540, USA

5. Shire, 300 Shire Way, Lexington, MA 02421, USA

6. Covance, Inc., 3635 Concorde Parkway, Suite 100 Chantilly, VA 20151, USA

Abstract

Identification and characterization of anti-drug antibodies is a critical component of biopharmaceutical drug development. The tiered approach for immunogenicity testing consists of screening, confirmatory, and characterization assays. Herein, we provide recommendations for confirmatory assays by expanding upon published guidance and present common practices across the industry. The authors recommend scientific approaches for development and validation of confirmatory assays using competition methods in ligand-binding assays, along with statistical formulae for routine use and validation. The paper will assist in understanding the confirmatory assay, and carefully implementing validation criteria a priori, as well as during sample analysis. These approaches represent the authors’ current knowledge and practices, with the aim that more uniform practices will be applied across the industry.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference33 articles.

1. Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

2. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products

3. FDA Draft guidance for industry. Assay development for immunogenicity testing of therapeutic proteins (2009). www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/default.htm.

4. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, EMEA/CHMP/BMWP/14327/2006 (2007). www.tga.gov.au/pdf/euguide/bmwp1432706en.pdf.

5. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3