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首页> 外文会议>Conference on scale-up and manufacturing of cell-based therapies V >SCALE-OUT OF MASSIVELY PARALLEL PATIENT-SPECIFIC CELL CULTURES WITH A MODIFIED TRANSPORTABLE CONDITIONED CELL CULTURE CHAMBER
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SCALE-OUT OF MASSIVELY PARALLEL PATIENT-SPECIFIC CELL CULTURES WITH A MODIFIED TRANSPORTABLE CONDITIONED CELL CULTURE CHAMBER

机译：用改性的可转移条件细胞培养室缩放大规模平行的患者特异性细胞培养物

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Barrier Isolators, which separate the cell culture processing atmosphere from the bioburden of personnel, are the best means to reduce contamination risks. These isolators are currently being used for cGMP-compliant clinical trials. Scaling cell production processes presents non-obvious restrictions to most people. Compared to open processing, modular Cytocentric isolators can be replicated to scale proportionately with each stage in cell processing until all steps are accommodated maximally. This allows a process to efficiently and quickly scale with operations from pre-clinical through clinical studies. However, for processing of massively parallel patient-specific cell cultures, incubation capacity in a barrier isolator, unlike in the open room, can be a bottleneck. Inexpensive and infinitely elastic incubation capacity can be provided by existing external incubators if cultures can be safely transported to and from the isolator for processing. We tested a modified transportable conditioned cell culture chamber (TC4) designed to enclose cell cultures inside the exterior incubator and fit through the airlocks of the barrier isolator to safely deliver cells to the interior for processing. We have previously published on good cell growth using this processing system to expand K562 cells, a hematopoietic stem cell-like cell line that has been used as a surrogate for CAR-T cell processing. In this study, we addressed sterility concerns by running mock production runs with a highly permissive color-changing bacterial broth. We ran three production runs, moving mock cultures between the barrier isolator and the external incubator with the TC4 transport chamber. We took samples of the final mock cell product, sealed them into sterile vials, and incubated them long-term, monitoring for bacterial growth. We also performed environmental monitoring of the barrier isolator processing chamber with an air sampler and contact plates. Positive control samples were all yellow and turbid. Negative samples and all test materials were negative for microbial growth. We concluded that this transport chamber could help safely alleviate the bottleneck in cell production presented by the unique needs of massively-parallel patient specific cell incubation.
机译：将细胞培养加工从人员生物养殖的屏障隔离器分开，是减少污染风险的最佳方法。这些隔离器目前正在用于CGMP标准的临床试验。缩放细胞生产过程对大多数人提供了非明显的限制。与开放处理相比，模块化细胞分离子分离器可以用细胞处理中的每个阶段按比例进行比例，直到所有步骤最大限度地容纳。这允许通过临床研究与临床前的操作有效和快速地规模。然而，为了加工大规模平行的患者特异性细胞培养物，在屏障隔离器中孵化容量，与在开放式房间不同，可以是瓶颈。如果可以安全地运输到隔离器以进行加工，则可以通过现有的外部培养箱提供廉价且无限的弹性孵化能力。我们测试了改进的可运输条件细胞培养室（TC4），该细胞培养室（TC4）设计成将电池培养物包围外部培养箱内部，并通过屏障隔离器的气锁配合，以安全地将电池递送到内部以进行处理。我们之前使用该处理系统出版了良好的细胞生长，以扩大K562细胞，造血干细胞样细胞系已被用作汽车-T细胞加工的替代物。在这项研究中，我们通过使用高允许的变色细菌肉汤运行的嘲弄生产来解决无菌问题。我们运行了三次生产，将屏障隔离器和外部培养箱之间移动模拟培养物与TC4传输室。我们采用了最终模拟细胞产品的样品，将它们密封成无菌小瓶，并长期孵育，监测细菌生长。我们还用空气采样器和接触板对阻挡隔离器处理室进行环境监测。阳性对照样品都是黄色和浑浊的。阴性样品和所有测试材料对于微生物生长为阴性。我们得出结论，该运输室可以帮助安全地缓解通过大规模平行患者特异性细胞孵育的独特需求所呈现的细胞生产中的瓶颈。

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