Effects of Sterilization on Cellobiose Dehydrogenase and Glucose Oxidase Based Glucose Biosensors

Richard Bennett, Arvind Rathore, Sébastien Gounel, Anna Lielpetere, Thomas M.B. Reichhart, Kavita Jayakumar, Roland Ludwig, Alfons K.G. Felice, Dónal Leech, Wolfgang Schuhmann, Andrew Mount, Nicolas Mano, Claudine Boiziau
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Abstract

Research on implantable glucose biosensors is driven by the need for innovative medical devices for continuous glucose monitoring in patients with diabetes mellitus. However, biosensor sterilization is a step that is widely omitted during the process of innovation. To compare the effects of gamma irradiation and chemical treatment with ethylene oxide (carbon microarray electrodes are fabricated, functionalized with glucose oxidizing enzymes (cellobiose dehydrogenase CDH or glucose oxidase GOx), and coated with a specifically designed zwitterionic polymer prior to the sterilization step. Cyclic voltammetry in the presence of 100 mm glucose of the biosensors before and after sterilization shows that gamma irradiation with a low radiation rate (25 kGy, 260 Gy h−1) does not induce a sensor performance loss, unlike the EtO treatment. In addition, no cytotoxic by-products are released after gamma sterilization. Based on these results obtained with both glucose oxidizing enzymes (CDH and GOx), gamma irradiation of the glucose biosensors with a low dose rate is preferable to exposure to EtO for biosensor terminal sterilization.

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灭菌对基于纤维生物糖脱氢酶和葡萄糖氧化酶的葡萄糖生物传感器的影响
对植入式葡萄糖生物传感器进行研究的动力来自于对用于糖尿病患者连续葡萄糖监测的创新医疗设备的需求。然而,在创新过程中,生物传感器的灭菌是一个被普遍省略的步骤。为了比较伽马辐照和环氧乙烷化学处理的效果,我们制作了碳微阵列电极,用葡萄糖氧化酶(纤维生物糖脱氢酶 CDH 或葡萄糖氧化酶 GOx)对其进行功能化处理,并在灭菌步骤之前涂上了专门设计的齐聚物聚合物。灭菌前后在 100 毫米葡萄糖存在下对生物传感器进行的循环伏安法测定表明,与环氧乙烷处理不同,低辐射率(25 kGy,260 Gy h-1)的伽马射线辐照不会导致传感器性能下降。此外,伽马射线灭菌后不会释放细胞毒性副产物。根据对两种葡萄糖氧化酶(CDH 和 GOx)的研究结果,在对生物传感器进行终端灭菌时,用低剂量率的伽马射线辐照葡萄糖生物传感器比用环氧乙烷辐照更有效。
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