Simulating extractables and leachables in biopharmaceutical manufacturing to support safety assessment

IF 4.7 3区 医学 Q1 PHARMACOLOGY & PHARMACY
Maximilian Bossong , Armin Hauk , Ina Pahl , Roberto Menzel , Peter Langguth
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引用次数: 0

Abstract

The use of single-use systems in the manufacturing of biopharmaceuticals raises concerns about the accumulation of process equipment-related leachables in their production and purification processes. However, this risk is mitigated by effective sinks in the manufacturing processes and dilution of product flow, for example, in tangential-flow-filtration. This paper presents a modeling approach that combines the release and adsorption of compounds with dynamic process conditions of biopharmaceutical processes. These calculations help assess process criticality by identifying sources but also low-risk processes and components regarding extractables and leachables accumulation. This approach can significantly reduce the necessity for resource-intensive practical testing, such as leachable studies, which may be impractical from an analytical perspective due to the complex matrices in biopharmaceutical process streams.

Abstract Image

模拟生物制药生产中的萃取物和浸出物以支持安全性评估。
在生物制药生产中使用一次性系统引起了人们对生产和纯化过程中与工艺设备相关的浸出物积累的关注。然而,这种风险可以通过生产过程中的有效吸收和产品流的稀释来减轻,例如在切向流过滤中。本文提出了一种将化合物的释放和吸附与生物制药过程的动态工艺条件相结合的建模方法。这些计算通过识别可提取物和可浸物积累的来源以及低风险过程和组件来帮助评估过程的临界性。这种方法可以显著减少资源密集型实际测试的必要性,例如可浸出研究,由于生物制药工艺流程中的复杂基质,从分析的角度来看,这可能是不切实际的。
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
CiteScore
9.60
自引率
2.20%
发文量
248
审稿时长
50 days
期刊介绍: The journal publishes research articles, review articles and scientific commentaries on all aspects of the pharmaceutical sciences with emphasis on conceptual novelty and scientific quality. The Editors welcome articles in this multidisciplinary field, with a focus on topics relevant for drug discovery and development. More specifically, the Journal publishes reports on medicinal chemistry, pharmacology, drug absorption and metabolism, pharmacokinetics and pharmacodynamics, pharmaceutical and biomedical analysis, drug delivery (including gene delivery), drug targeting, pharmaceutical technology, pharmaceutical biotechnology and clinical drug evaluation. The journal will typically not give priority to manuscripts focusing primarily on organic synthesis, natural products, adaptation of analytical approaches, or discussions pertaining to drug policy making. Scientific commentaries and review articles are generally by invitation only or by consent of the Editors. Proceedings of scientific meetings may be published as special issues or supplements to the Journal.
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