Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of vaccines and biological therapeutics manufacturers

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2023-02-01 DOI:10.1016/j.biologicals.2022.11.002

Elliot Lilley , Emmanuelle Coppens , Pradip Das , Francis Galaway , Richard Isbrucker , Sarah Sheridan , Paul Stickings , Anthony Holmes

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引用次数: 3

Abstract

The UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) has been tasked by the World Health Organization (WHO) to review the extent to which animal-based testing methods are described in their manuals, guidelines and recommendations for vaccines and biotherapeutics. The aim is to identify and recommend where updates to these documents can lead to an increased and more harmonised adoption of 3Rs principles (i.e. Replacement, Reduction and Refinement of animal tests) in the quality control and batch release testing requirements for vaccines and biotherapeutics. Developing recommendations that are widely applicable by both the manufacturers and national regulatory authorities for vaccines and biologicals globally requires a detailed understanding of how different organisations view the opportunities and barriers to better integration of the 3Rs. To facilitate this, we developed and distributed a survey aimed at vaccine and biotherapeutics manufacturers in July 2021. In this paper, we present the key findings from this survey and how these will help inform the recommendations for wider integration of 3Rs approaches by WHO in their guidance documents applicable to the quality control and batch testing of vaccines and biotherapeutics.

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将3Rs方法纳入世卫组织生物制剂批量放行检测指南:对疫苗和生物疗法生产商调查的反应

世界卫生组织（世界卫生组织）委托英国国家研究动物替代、改良和减少中心（NC3Rs）审查其疫苗和生物治疗手册、指南和建议中对动物检测方法的描述程度。目的是确定并建议对这些文件的更新可以在疫苗和生物治疗学的质量控制和批量放行测试要求中更多、更协调地采用3Rs原则（即动物试验的替代、减少和改进）。制定广泛适用于全球疫苗和生物制品制造商和国家监管机构的建议，需要详细了解不同组织如何看待3R更好整合的机会和障碍。为了促进这一点，我们于2021年7月制定并分发了一项针对疫苗和生物治疗药物制造商的调查。在本文中，我们介绍了这项调查的主要结果，以及这些结果将如何有助于为世界卫生组织在其适用于疫苗和生物治疗的质量控制和批量测试的指导文件中更广泛地整合3Rs方法的建议提供信息。

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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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.