Optimization of Methodologies to Study Freeze/Thaw Processes in Drug Substance Bottles.

IF 2.3 Q3 BIOCHEMICAL RESEARCH METHODS Methods and Protocols Pub Date : 2024-09-04 DOI:10.3390/mps7050068
Sarah S Peláez, Hanns-Christian Mahler, Jörg Huwyler, Andrea Allmendinger
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Abstract

Biological drug substance (DS) is often frozen to enhance storage stability, prolong shelf life, and increase flexibility during manufacturing. However, the freezing and thawing (F/T) of bulk DS at the manufacturing scale can impact product quality as a result of various critical conditions, including cryo-concentration during freezing, which are influenced, among other things, by product-independent process parameters (e.g., container type, fill level, F/T equipment, and protocols). In this article, we report the optimization of two major methodologies to study product-independent process parameters in DS bottles at the manufacturing scale, namely the recording of temperature profiles and liquid sampling after thawing to quantify the concentration gradients in the solution. We report experimentally justified measuring positions for temperature recordings, especially for the selection of the last point to freeze position, and highlight the implementation of camera-assisted inspection to determine the last point to thaw and the actual thawing time. In particular, we provide, for the first time, a detailed description of the technical implementation of these two measuring set-ups. Based on the reported case studies, we recommend choosing relevant measuring positions as a result of initial equipment characterization, resulting in a resource-conscious study set-up.

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优化研究药物瓶中冻融过程的方法。
生物药物 (DS) 通常需要冷冻,以提高储存稳定性、延长保质期并增加生产过程中的灵活性。然而,散装 DS 在生产过程中的冷冻和解冻 (F/T) 会因各种关键条件(包括冷冻过程中的低温浓度)而影响产品质量,而这些关键条件主要受与产品无关的工艺参数(如容器类型、填充水平、F/T 设备和规程)的影响。在本文中,我们报告了对两种主要方法的优化,以研究 DS 瓶在生产过程中与产品无关的工艺参数,即记录温度曲线和解冻后的液体取样,以量化溶液中的浓度梯度。我们报告了实验证明的温度记录测量位置,特别是最后冻结点位置的选择,并重点介绍了相机辅助检测的实施情况,以确定最后解冻点和实际解冻时间。特别是,我们首次详细介绍了这两种测量设置的技术实施情况。根据所报告的案例研究,我们建议根据最初的设备特性选择相关的测量位置,从而实现资源节约型的研究设置。
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来源期刊
Methods and Protocols
Methods and Protocols Biochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (miscellaneous)
CiteScore
3.60
自引率
0.00%
发文量
85
审稿时长
8 weeks
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