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Ghost Cells for Mechanical Circulatory Support In Vitro Testing: A Novel Large Volume Production.
Biotechnology Journal ( IF 3.2 ) Pub Date : 2020-01-22 , DOI: 10.1002/biot.201900239
Malte Schöps 1 , Johanna C Clauser 1 , Matthias F Menne 1 , Dennis Faßbänder 1 , Thomas Schmitz-Rode 1 , Ulrich Steinseifer 1, 2 , Jutta Arens 1
Affiliation  

The aim of this work is to establish a large volume batch production system to produce sufficient volumes of ghost cells to facilitate hemolysis testing of mechanical circulatory support devices. A volume of more than 405 mL with a hematocrit of at least 28% is required to perform in vitro hemolysis testing of mechanical circulatory support devices according to international standards. The established ghost cell production method performed at the institute is limited to 3.1 mL of concentrated cells, that is, cells with 100% hematocrit, due to predominantly manual process steps. Through semi-automation of the existing method by using the large volume batch production system, productivity is increased 60-fold to 188 mL while almost doubling process efficiency to 23.5%. Time-consuming manual work such as pipetting is now supported by sensor-based process engineering. With the help of the large volume batch production system, the objective of producing large quantities of ghost cells is successfully achieved. Thus, this work lays the foundation for spatially resolved hemolysis evaluation of mechanical circulatory support devices in combination with the small-scale fluorescent hemolysis detection method.

中文翻译:

用于机械循环支持的鬼细胞体外测试:一种新型的大批量生产。

这项工作的目的是建立一个大批量生产系统,以生产足够数量的鬼细胞,以便于对机械循环支持设备进行溶血测试。根据国际标准,对机械循环支持设备进行体外溶血测试需要超过405 mL的血细胞比容至少28%。由于主要是手动处理步骤,因此在研究所执行的建立的鬼细胞生产方法仅限于3.1 mL浓缩细胞,即血细胞比容为100%的细胞。通过使用大批量生产系统对现有方法进行半自动化,生产率提高了60倍,达到188 mL,而处理效率几乎翻了一番,达到23.5%。基于传感器的过程工程现在支持耗时的手动工作,例如移液。借助于大批量生产系统,成功实现了生产大量鬼细胞的目的。因此,这项工作为结合小型荧光溶血检测方法的机械循环支持设备的空间分辨溶血评估奠定了基础。
更新日期:2020-01-22
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