病毒清除风险管理：关于采用平台验证方法和流程变更风险管理的案例研究。

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals Pub Date : 2024-08-01 DOI:10.1016/j.biologicals.2024.101786

Na Liu, Runze Wu

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引用次数: 0

摘要

在生物制药进入临床试验或商业上市之前，通常需要进行病毒清除 (VC) 研究。随着前期知识和经验的增加，平台验证可用于取消某些 VC 研究，这种策略已被更新到行业指南中，如 ICH Q5A (R2)。此外，在产品的生命周期管理过程中可能会发生工艺变更。在这种情况下，需要确定高风险工艺参数并制定相应的控制策略，以确保产品的病毒安全性。这项工作介绍了以科学为基础的风险管理工具的设计，以及如何将该工具用于平台验证和工艺变更情况。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Risk management for viral clearance: A case study on adoption of platform validation approach and risk management of process changes

Viral clearance (VC) studies are routinely required prior to entering clinical trials or for commercial launch of biopharmaceuticals. With increasing prior knowledge and experience, platform validation can be used to eliminate some VC studies and such strategy has been updated into industry guidelines, such as ICH Q5A (R2). In addition, process changes can happen during life-cycle management of a product. In these circumstances, high-risk process parameters need to be identified and corresponding control strategies need to be defined to ensure viral safety of the product. This work describes the design of a science-based risk management tool and how this tool is employed for platform validation and process change scenarios.

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来源期刊

Biologicals 生物-生化研究方法

CiteScore

3.70

自引率

0.00%

发文量

审稿时长

48 days

期刊介绍： Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.