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从高通量和多重分析角度看生物治疗药物生物分析的新兴技术:来自美国药学协会新兴技术行动项目委员会的见解

Emerging technologies for biotherapeutic bioanalysis from a high-throughput and multiplexing perspective: insights from an AAPS emerging technology action program committee.

作者信息

Purushothama Shobha, Dysinger Mark, Chen Yao, Österlund Karolina, Mora Johanna, Chunyk Allison Given, Peloquin Russ

机构信息

Development Biomarkers & Bioanalytical Sciences, Biogen, Cambridge, MA 02142, USA.

Alexion Pharmaceuticals, New Haven, CT 06510, USA.

出版信息

Bioanalysis. 2018 Feb;10(3):181-194. doi: 10.4155/bio-2017-0196. Epub 2018 Jan 18.

Abstract

This manuscript aims to provide insights and updates on emerging technologies from a throughput and multiplexing perspective and to update readers on changes in previously reported technologies. The technologies discussed range from nascent (ultrasensitive Cira, Intellicyt, Dynaxi and Captsure™) to the more established (Ella and SQIDlite™). For the nascent technologies, there was an emphasis on user interviews and reviews, where available, to help provide an unbiased view to our readers. For the Ella, a review of published user data as well as author and other user experiences are summarized. Due to their emergent nature, all the technologies described are applicable in the early drug development stage, may require an upfront investment of capital and may not perform as expected.

摘要

本手稿旨在从通量和多路复用的角度提供关于新兴技术的见解和更新内容,并向读者介绍先前报道技术的变化情况。所讨论的技术涵盖从新兴技术(超灵敏的Cira、Intellicyt、Dynaxi和Captsure™)到较为成熟的技术(Ella和SQIDlite™)。对于新兴技术,如有可用的用户访谈和评论,会加以强调,以便为读者提供公正的观点。对于Ella,总结了已发表的用户数据以及作者和其他用户的经验。由于这些技术的新兴性质,所描述的所有技术都适用于药物早期研发阶段,可能需要前期资本投入,且可能无法达到预期效果。

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