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Strategy for Selecting Disposable Bags for Cell Culture Media Applications Based on a Root-Cause Investigation

机译：基于根本原因研究的细胞培养基应用一次性包装袋选择策略

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The use of disposable bags for cell culture media storage has grown significantly in the past decade. Some of the key advantages of using disposable bags relative to non-disposable containers include increased product throughput, decreased cleaning validation costs, reduced risk of cross contamination and lower facility costs. As the scope of use of disposable bags for cell culture applications increases, problematic bags and scenarios should be identified and addressed to continue improving disposables technologies and meet the biotech industry's needs. In this article, we examine a cell culture application wherein media stored in disposable bags is warmed at 37° C before use for cell culture operations. A problematic bag film was identified through a prospective and retrospective cell culture investigation. The investigation provided information on the scope and variation of the issue with respect to different Chinese hamster ovary (CHO) cell lines, cell culture media, and application-specific parameters. It also led to the development of application-specific test methods and enabled a strategy for disposable bag film testing. The strategy was implemented for qualifying an alternative bag film for use in our processes. In this test strategy, multiple lots of 13 bag film types, encompassing eight vendors were evaluated using a three round, cell culture-based test strategy. The test strategy resulted in the determination of four viable bag film options based on the technical data. The results of this evaluation were used to conclude that a volatile or air-quenched compound, likely generated by gamma irradiation of the problematic bag film, negatively impacted cell culture performance.
机译：在过去的十年中，将一次性袋子用于细胞培养基的存储已显着增长。相对于非一次性容器，使用一次性袋子的一些关键优势包括提高产品通过量，降低清洁确认成本，降低交叉污染的风险和降低设备成本。随着一次性袋在细胞培养应用中的使用范围的扩大，应确定并解决有问题的袋和方案​​，以继续改进一次性技术并满足生物技术行业的需求。在本文中，我们研究了细胞培养应用，其中存储在一次性袋子中的培养基在用于细胞培养操作之前要先加热到37°C。通过前瞻性和回顾性细胞培养研究鉴定出有问题的袋子薄膜。该调查提供了有关不同中国仓鼠卵巢（CHO）细胞系，细胞培养基和应用程序特定参数的问题范围和变化的信息。这也导致了针对特定应用的测试方法的开发，并为一次性袋膜测试提供了一种策略。实施该策略是为了使可在我们的流程中使用的替代袋膜合格。在此测试策略中，使用基于细胞培养的三轮测试策略对包括8个供应商在内的13种袋式薄膜进行了多批次评估。该测试策略根据技术数据确定了四个可行的袋膜选项。该评估的结果用于得出结论，可能是由问题袋子薄膜的伽马射线辐照产生的挥发性或空气骤冷化合物，对细胞培养性能产生了负面影响。

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