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检测方法学类型:全球生物分析联盟协调小组的最佳实践和协调建议。

Assay formats: Recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team.

机构信息

Novartis Pharma AG, Novartis Institute for Biomedical Research, 144 Klybeckstrasse, 4052, Basel, Switzerland,

出版信息

AAPS J. 2014 Mar;16(2):194-205. doi: 10.1208/s12248-013-9552-9. Epub 2013 Dec 17.

DOI:10.1208/s12248-013-9552-9
PMID:24343771
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3933581/
Abstract

As part of the GBC (Global Bioanalysis Consortium), the L3 assay format team has focused on reviewing common platforms used to support ligand binding assays in the detection of biotherapeutics. The following review is an overview of discussions and presentations from around the globe with a group of experts from different companies to allow an international harmonization of common practices and suggestions for different platforms. Some of the major platforms include Gyrolab, Erenna, RIA, AlphaLISA, Delfia, Immuno-PCR, Luminex, BIAcore, and ELISAs. The review is meant to support bioanalysts in taking decisions between different platforms depending on the needs of the analyte with a number of recommendations to help integration of platforms into a GLP environment.

摘要

作为 GBC(全球生物分析联盟)的一部分,L3 检测方法团队专注于审查用于支持生物治疗药物检测的配体结合检测中常用的平台。以下综述概述了来自全球各地的讨论和演讲,这些讨论和演讲的参与者是来自不同公司的一组专家,旨在实现不同平台的常见做法和建议的国际协调统一。一些主要的平台包括 Gyrolab、Erenna、RIA、AlphaLISA、Delfia、免疫-PCR、Luminex、BIAcore 和 ELISA。该综述旨在支持生物分析人员根据分析物的需求在不同平台之间做出决策,并提供了一些建议,以帮助将平台整合到 GLP 环境中。

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