Measurement of mRNA therapeutics: method development and validation challenges

Henderson Neil; Wilson Amanda

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Measurement of mRNA therapeutics: method development and validation challenges

机译：mRNA治疗方法的测量：方法开发和验证挑战

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The progression of chemically modified mRNA therapeutics through development pipelines is accelerating for many disease indications and the need to assess these analytes is becoming more routine for the pharmaceutical industry and contract research organizations. This article describes some of the challenges and strategies for performing regulated bioanalysis of modified mRNA therapeutics by comparing the two main analytical approaches - quantitative reverse transcription PCR and branched DNA.

机译：通过发育管道的化学改性mRNA治疗剂的进展正在加速许多疾病指示，评估这些分析物的需要是制药行业和合同研究组织的常规。本文介绍了通过比较两种主要分析方法 - 定量逆转录PCR和支链DNA来介绍对改性mRNA治疗剂进行调节生物分析的一些挑战和策略。

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来源
《Bioanalysis》 |2019年第21期|共8页
作者
Henderson Neil; Wilson Amanda;
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作者单位

AstraZeneca Translat Biomarkers &

Bioanal Clin Pharmacol Biol &

Bioanalyt Clin Pharmacol &

AstraZeneca Translat Biomarkers &

Bioanal Clin Pharmacol Biol &

Bioanalyt Clin Pharmacol &

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原文格式 PDF
正文语种 eng
中图分类生物科学;
关键词
branched DNA (bDNA); modified messenger RNA (mRNA); quantitative reverse transcription PCR (qRT-PCR); regulatory bioanalysis;

机译：分支DNA（BDNA）;修饰的信使RNA（mRNA）;定量逆转录PCR（QRT-PCR）;调控生物分析;

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1. Measurement of mRNA therapeutics: method development and validation challenges [J] . Henderson Neil, Wilson Amanda Bioanalysis . 2019,第21期

机译：mRNA治疗方法的测量：方法开发和验证挑战
2. Cross-validation of a mass spectrometric-based method for the therapeutic drug monitoring of irinotecan: implementation of matrix-assisted laser desorption/ionization mass spectrometry in pharmacokinetic measurements [J] . Calandra Eleonora, Posocco Bianca, Crotti Sara, Analytical and bioanalytical chemistry . 2016,第19期

机译：基于质谱的伊立替康治疗药物监测方法的交叉验证：药代动力学测量中基质辅助激光解吸/电离质谱的实现
3. Cross-validation of a mass spectrometric-based method for the therapeutic drug monitoring of irinotecan: implementation of matrix-assisted laser desorption/ionization mass spectrometry in pharmacokinetic measurements [J] . Calandra Eleonora, Posocco Bianca, Crotti Sara, Analytical and bioanalytical chemistry . 2016,第19期

机译：基于质谱的伊立替康治疗药物监测方法的交叉验证：药代动力学测量中基质辅助激光解吸/电离质谱的实现
4. DEVELOPMENT AND VALIDATION OF AN ASSAY FOR QUANTITATION OF A THERAPEUTIC PROTEIN IN HUMAN URINE USING AN LC/MS/MS METHOD [C] . David Roos, John Yu, Jeffrey Duggan, American Society for Mass Spectrometry Conference on Mass Spectrometry and Allied Topics . 2013

机译：使用LC / MS / MS法测定对人尿中治疗蛋白的测定的开发和验证
5. Development and application of a validated method for measurements of ammonia emissions from in-use vehicles on a chassis dynamometer. [D] . Livingston, Cody Garrett. 2008

机译：开发和应用经过验证的底盘测功机测量在用车辆中氨气排放的方法。
6. Occupational kneeling and squatting: development and validation of an assessment method combining measurements and diaries [O] . Dirk M. Ditchen, Rolf P. Ellegast, Tom Gawliczek, -1

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7. Development of whole body scanning PCR, a highly sensitive method to study the biodistribution of mRNAs, noncoding RNAs and therapeutic oligonucleotides [O] . Boos Julien Alfred Jean-Paul 2015

机译：开发全身扫描pCR，一种研究mRNa，非编码RNa和治疗性寡核苷酸的生物分布的高度灵敏的方法

Measurement of mRNA therapeutics: method development and validation challenges

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