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今天的一次性使用技术 - 应用程序的丰富多彩

Diego R Schmidhalter¹, Dieter Eibl², Regine Eibl³

¹Alpha Lyncis SA, Rue Charles-Clos Olsommer 1, CH-3968 Veyras, Switzerland. diego.schmidhalter@alphalyncis.com.

|May 29, 2025

概括

单次使用技术 (SUT) 由于其好处,在生物制药制造业中被广泛采用. 这一审查涵盖SUT产品,应用,以及瑞士.

科学领域:

生物技术和制药制造业的发展
工艺工程的过程工程.
材料科学材料科学材料科学

背景情况:

一次性使用技术 (SUT) 在经典生物制药和先进治疗药物 (ATMP) 制造中越来越普遍.
SUT的优势,包括灵活性和降低污染风险,推动其在实验室和生产环境中得到广泛采用.

研究的目的:

提供可用的一次性产品,制造商和供应商的最新概述.
讨论过程示例,设施设计和SUT实现的配置.
突出瑞士在SUT开发和采用方面的领导作用.

主要方法:

审查一次性使用系统和平台技术的里程碑.
分析当前的市场供应和供应商环境.
在生物制药过程中实施SUT的案例研究.

主要成果:

从实验室应用到大规模生产,SUT在各种规模上广泛使用.
市场提供来自众多供应商的广泛的SUT产品.
SUT的采用范围超出生物制药行业,这表明其适用性更广泛.

结论:

单一用途技术是生物处理领域及其他领域中一个成熟且不断扩大的领域.
持续开发和实施SUT,特别是瑞士创新,正在塑造现代制造业.
SUT提供了显著的优势,导致其无处不在的存在和持续集成到各种工业应用中.

关键词:

生物治疗学生物治疗学过程强化和连续制造.一次性使用设施.一次性使用系统和工艺平台

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