A practical approach to automate randomized design of experiments for ligand-binding assays

Author:

Tsoi Jennifer1,Patel Vimal2,Shih Judy2

Affiliation:

1. Department of Molecular & Medical Pharmacology, Crump Institute for Molecular Imaging, University of California, Los Angeles, CA 90095, USA.

2. Department of Pharmacokinetic & Drug Metabolism, Amgen Inc. One Amgen Center Drive, Thousand Oaks, CA 91320, USA

Abstract

Background: Design of experiments (DOE) is utilized in optimizing ligand-binding assay by modeling factor effects. To reduce the analyst’s workload and error inherent with DOE, we propose the integration of automated liquid handlers to perform the randomized designs. Results: A randomized design created from statistical software was imported into custom macro converting the design into a liquid-handler worklist to automate reagent delivery. An optimized assay was transferred to a contract research organization resulting in a successful validation. Conclusion: We developed a practical solution for assay optimization by integrating DOE and automation to increase assay robustness and enable successful method transfer. The flexibility of this process allows it to be applied to a variety of assay designs.

Publisher

Future Science Ltd

Subject

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

Reference10 articles.

1. International Conference on Harmonisation of Technical Requirements For Registration of Pharmaceuticals for Human Use.Validation of Analytical Procedures: Text and Methodology Q2(R1).(2005).

2. Montgomery DC.Design and Analysis of Experiments. (6th Edition).John Wiley & Sons, NJ, USA (2005).

3. Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins

4. Optimizing ELISAs for precision and robustness using laboratory automation and statistical design of experiments

5. Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules

Cited by 6 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

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