Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics.

IF 3 3区 生物学 Q2 BIOCHEMICAL RESEARCH METHODS
ELECTROPHORESIS Pub Date : 2025-06-25 DOI:10.1002/elps.70004
Anne B Ries, Maximilian N Merkel, Kristina Coßmann, Marina Paul, Robin Grunwald, Daniel Klemmer, Franziska Hübner, Sabine Eggensperger, Frederik T Weiß
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引用次数: 0

Abstract

In pharmaceutical quality control (QC), analytical methods need to maintain release analytics over decades. Over a product's lifecycle, vendors may update instrument hardware and/or software, or a switch between vendors may become necessary upon discontinuation of an instrument. Both situations pose a challenge to pharmaceutical QC.We designed an efficient instrument comparability study to gain a comprehensive understanding of potential performance differences between instruments and therefore rationalize the risk assessment and decision process for a path forward. The results may either point out whether a full or partial re-validation is necessary or whether a science-based update can be pursued based on the data generated in the study. The study design is universally applicable to a substantial range of release analytical methods. In a straightforward setup of two experiments with the new instrument, a statistically meaningful data set is generated for comparison with available historical or validation data of the original instrument. In a Good Manufacturing Practice (GMP) environment, we implemented the study design in a benchmark study comparing the ICE3 and Maurice C imaged capillary isoelectric focusing (icIEF) instruments. The core-study confirmed equal or better performance of the Maurice C in all parameters and serves as a basis for seamless continuation of release icIEF measurements on Maurice C.

药物释放分析中仪器变化的通用研究设计。
在药品质量控制(QC)中,分析方法需要保持释放分析数十年。在产品的生命周期中,供应商可能会更新仪器硬件和/或软件,或者在仪器停产时可能需要在供应商之间切换。这两种情况都对药品质量控制提出了挑战。我们设计了一项有效的工具可比性研究,以全面了解工具之间潜在的性能差异,从而使风险评估和决策过程合理化。结果可能会指出是否需要完全或部分重新验证,或者是否可以根据研究中产生的数据进行基于科学的更新。该研究设计普遍适用于大量的释放分析方法。在使用新仪器进行的两个实验的简单设置中,生成具有统计意义的数据集,以便与原始仪器的可用历史或验证数据进行比较。在良好生产规范(GMP)的环境下,我们在比较ICE3和Maurice C成像毛细管等电聚焦(icIEF)仪器的基准研究中实施了研究设计。核心研究证实了Maurice C在所有参数上的相同或更好的性能,并作为对Maurice C的释放icIEF测量的无缝延续的基础。
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
ELECTROPHORESIS
ELECTROPHORESIS 生物-分析化学
CiteScore
6.30
自引率
13.80%
发文量
244
审稿时长
1.9 months
期刊介绍: ELECTROPHORESIS is an international journal that publishes original manuscripts on all aspects of electrophoresis, and liquid phase separations (e.g., HPLC, micro- and nano-LC, UHPLC, micro- and nano-fluidics, liquid-phase micro-extractions, etc.). Topics include new or improved analytical and preparative methods, sample preparation, development of theory, and innovative applications of electrophoretic and liquid phase separations methods in the study of nucleic acids, proteins, carbohydrates natural products, pharmaceuticals, food analysis, environmental species and other compounds of importance to the life sciences. Papers in the areas of microfluidics and proteomics, which are not limited to electrophoresis-based methods, will also be accepted for publication. Contributions focused on hyphenated and omics techniques are also of interest. Proteomics is within the scope, if related to its fundamentals and new technical approaches. Proteomics applications are only considered in particular cases. Papers describing the application of standard electrophoretic methods will not be considered. Papers on nanoanalysis intended for publication in ELECTROPHORESIS should focus on one or more of the following topics: • Nanoscale electrokinetics and phenomena related to electric double layer and/or confinement in nano-sized geometry • Single cell and subcellular analysis • Nanosensors and ultrasensitive detection aspects (e.g., involving quantum dots, "nanoelectrodes" or nanospray MS) • Nanoscale/nanopore DNA sequencing (next generation sequencing) • Micro- and nanoscale sample preparation • Nanoparticles and cells analyses by dielectrophoresis • Separation-based analysis using nanoparticles, nanotubes and nanowires.
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