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A Cytotoxic Leachable Compound from Single-Use Bioprocess Equipment that Causes Poor Cell Growth Performance

机译：一次性生物工艺设备产生的细胞毒性可浸出化合物，可导致不良的细胞生长性能

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摘要

A current trend in the production of biopharmaceuticals is the replacement of fixed stainless steel fluid-handling units with disposable plastic bags. Such single-use systems (SUS) offer numerous advantages, but also introduce a new set of materials into the production process and consequently expose biomanufacturers to a new set of risks related to those materials, not to mention reliance on an entirely new supply chain. In the course of developing and conducting a cell-growth-based test for suitability of disposable plastic components destined for use in cell culture operations, we discovered that the cytotoxic compound bis(2,4-di-tert-butylphenyl)phosphate (bDtBPP) leaches out of certain bags and into cell culture media in concentrations that are deleterious to cell growth. Specifically, media held in certain bags for several days at 37°C was found to contain bDtBPP, and use of those held-media samples in cell growth experiments provides data that overlap neatly with cell growth experiments using media spiked directly with bDtBPP, proving that bDtBPP leaching is responsible for the reduced growth attributable to those SUS bags. Overall, this issue represents a risk to the production of biopharmaceuticals in SUS, a risk that must be managed by diligent collaboration among companies along the entire supply chain for SUS components.
机译：生物制药生产中的当前趋势是用一次性塑料袋代替固定的不锈钢流体处理装置。这样的一次性系统（SUS）具有许多优势，但也将新的材料引入生产过程，从而使生物制造商面临与这些材料相关的新的风险，更不用说依赖全新的供应链了。在针对用于细胞培养操作的一次性塑料组件的开发和进行基于细胞生长的测试过程中，我们发现细胞毒性化合物双（2,4-二叔丁基苯基）磷酸酯（bDtBPP）从某些袋子中浸出并进入对细胞生长有害的浓度的细胞培养基。具体而言，发现在37°C的某些袋中保存的培养基中含有bDtBPP，在细胞生长实验中使用这些保存的培养基样品提供的数据与使用直接掺入bDtBPP的培养基的细胞生长实验完全重叠，证明了bDtBPP浸出是造成这些SUS袋减少的增长的原因。总体而言，此问题代表着在SUS中生产生物制药的风险，这一风险必须通过整个SUS组件供应链中各公司之间的勤奋合作来加以管理。

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