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利用分析平台技术支持加速产品开发——概念审查和案例研究。

Using Analytical Platform Technologies to Support Accelerated Product Development-Concept Review and Case Study.

机构信息

AstraZeneca Biologics, Gaithersburg, MD

出版信息

PDA J Pharm Sci Technol. 2022 May-Jun;76(3):248-262. doi: 10.5731/pdajpst.2021.012647. Epub 2021 Oct 18.

Abstract

The number of products being developed for serious conditions that are eligible for expedited programs has been increasing in recent years. This article presents an industry perspective on how to reduce analytical life cycle steps when using analytical platform technologies (APT) in support of accelerated biological product development. Strategies for life cycle steps for APT methods are conceptually reviewed within the framework of supporting chemistry, manufacturing, and control (CMC) development acceleration. Reduced method qualification, transfer, and validation studies could be performed, provided that the initially validated test method remains unchanged. A detailed case study is used to illustrate considerations for the initial method validation and subsequent APT verification studies. Considerations for APT implementation are discussed and suggestions are provided for the submission of APT information in regulatory filings.

摘要

近年来,有越来越多针对严重疾病且符合加速审批程序的产品正在研发。本文从行业角度出发,探讨了在支持生物制品加速开发过程中使用分析平台技术(APT)时,如何减少分析周期步骤。本文在支持化学、制造和控制(CMC)开发加速的框架内,从概念上对 APT 方法的生命周期步骤策略进行了审查。只要最初验证的测试方法保持不变,则可以进行减少方法验证、转移和确认研究。详细的案例研究用于说明初始方法验证和随后的 APT 验证研究的注意事项。本文还讨论了 APT 实施的注意事项,并就法规申报中 APT 信息的提交提出了建议。

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