Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum

Author:

der Strate Barry van1,Longdin Robin2,Geerlings Marie1,Bachmayer Nora3,Cavallin Maria4,Litwin Virginia5,Patel Minesh6,Passe-Coutrin Wilfried7,Schoelch Corinna8,Companjen Arjen3,Fjording Marianne Scheel9

Affiliation:

1. PRA Health Sciences, Amerikaweg 18, 9407 TK, Assen, The Netherlands

2. LGC Ltd, Fordham, Cambridgeshire, UK

3. Janssen ID&V, Leiden, The Netherlands

4. AstraZeneca, Macclesfield, UK

5. Covance Central Laboratory Services, Indianapolis, IN 46214, USA

6. Eurofins Pharma Bioanalysis Services, Abingdon, UK

7. Sanofi, Alfortville, France

8. Boehringer Ingelheim, Biberach an der Riss, Germany

9. Novo Nordisk A/S, Måløv, Denmark

Abstract

Flow cytometry is a powerful tool that can be used for the support of (pre)clinical studies. Although various white papers are available that describe the set-up and validation of the instrumentation (the flow cytometer) and validation of flow cytometry methods, to date no guidelines exist that address the requirements for performing flow cytometry in a regulated environment. In this manuscript, the European Bioanalysis Forum presents additional practice guidance on the use of flow cytometry in the support of drug development programs and addresses areas that are not covered in the previous publications. The concepts presented here are based on the consensus of discussions in the European Bioanalysis Forum Topic Team 32, in meetings in Barcelona, Limelette and multiple telephone conferences.

Publisher

Future Science Ltd

Subject

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

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