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首页> 外文期刊>Biotechnology Progress >Verification of a New Biocompatible Single-Use Film Formulation with Optimized Additive Content for Multiple Bioprocess Applications
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Verification of a New Biocompatible Single-Use Film Formulation with Optimized Additive Content for Multiple Bioprocess Applications

机译：用于多种生物工艺应用的具有最佳添加剂含量的新型生物相容性一次性薄膜制剂的验证

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Single-use bioprocessing bags and bioreactors gained significant importance in the industry as they offer a number of advantages over traditional stainless steel solutions. However, there is continued concern that the plastic materials might release potentially toxic substances negatively impacting cell growth and product titers, or even compromise drug safety when using single-use bags for intermediate or drug substance storage. In this study, we have focused, on the in vitro detection of potentially cytotoxic leachables originating from the recently developed new polyethylene (PE) multilayer film called S80. This new film was developed to guarantee biocompatibility for multiple bioprocess applications, for example, storage of process fluids, mixing, and cell culture bioreactors. For this purpose, we examined a protein-free cell culture medium that had been used to extract leachables from freshly gamma-irradiated sample bags in a standardized cell culture assay. We investigated sample bags from films generated to establish the operating ranges of the film extrusion process. Further, we studied sample bags of different age after gamma-irradiation and finally, we performed extended media extraction trials at cold room conditions using sample bags. In contrast to a nonoptimized film formulation, our data demonstrate no cytotoxic effect of the S80 polymer film formulation under any of the investigated conditions. The S80 film formulation is based on an optimized PE polymer composition and additive package. Full traceabil-ity alongside specifications and controls of all critical raw materials, and process controls of the manufacturing process, that is, film extrusion and gamma-irradiation, have been established to ensure lot-to-lot consistency.
机译：一次性生物处理袋和生物反应器在行业中变得尤为重要，因为它们比传统的不锈钢解决方案具有许多优势。但是，人们仍然担心塑料材料可能释放出潜在的有毒物质，从而对细胞生长和产品滴度产生负面影响，甚至在使用一次性袋子进行中间或药物存储时，甚至损害药物安全性。在这项研究中，我们集中于体外检测源自最近开发的称为S80的新型聚乙烯（PE）多层膜的潜在细胞毒性可浸出物。研发这种新膜的目的是保证其在多种生物工艺应用中的生物相容性，例如，工艺流体的存储，混合和细胞培养生物反应器。为此，我们检查了一种无蛋白质的细胞培养基，该培养基已用于在标准化细胞培养测定法中从新鲜的γ射线辐照的样品袋中提取可浸出物。我们调查了产生的薄膜的样品袋，以确定薄膜挤出过程的操作范围。此外，我们研究了伽玛射线辐照后不同年龄的样品袋，最后，我们在寒冷的房间条件下使用样品袋进行了扩展的介质萃取试验。与未优化的薄膜配方相反，我们的数据表明，在任何研究的条件下，S80聚合物薄膜配方均无细胞毒性作用。 S80薄膜配方基于优化的PE聚合物组成和添加剂包。建立了完全可追溯性以及所有关键原材料的规范和控制，以及制造过程的过程控制，即薄膜挤出和伽马射线辐照，以确保批次之间的一致性。

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