Sugahara Yoshimi, Mizuno Mitsuru, Miyashita Noe, Katano Hisako, Sekiya Ichiro
Solution Development Department, Pharmaceutical & Biopharmaceuticals Engineering Division, Hitachi Plant Services Co., Ltd., 1-1, Higashi-ikebukuro 3-chome, Toshima-ku, Tokyo 170-6034, Japan.
Center for Stem Cell and Regenerative Medicine, Institute of Science Tokyo, 1-5-45, Bunkyo-ku, Yushima, Tokyo 113-8519, Japan.
Regen Ther. 2025 Apr 12;29:397-403. doi: 10.1016/j.reth.2025.03.020. eCollection 2025 Jun.
The field of regenerative medicine is rapidly evolving, with an increasing number of approved cell preparations. However, cell processing facilities (CPFs) still heavily rely on manual operations by cell processing operators (CPOs). The intricate nature of cell culture and stringent sterility requirements impose a considerable psychological burden on CPOs, particularly the risk of cell contamination. This study delves into the psychological aspects experienced by CPOs in relation to the risk of contamination during cell culture. An online survey was conducted across 47 sites to investigate concerns regarding contamination and the strategies implemented to mitigate contamination risk in cell processing facilities. The survey findings revealed that 72 % of operators expressed concern about contamination, with 18 % reporting direct experiences of contamination. This indicates that the perceived contamination risk in CPFs is higher than the actual reported incidents. Furthermore, this study examines operational practices, such as material handling, and the utilization of biological safety cabinets (BSCs). The results highlight variations in BSC utilization and material handling practices, underscoring potential operational challenges. Implementing risk assessments and leveraging evidence-based data at each site could help address these challenges and alleviate the psychological strain on CPOs. This, in turn, would enhance the quality of cell therapy products and improve the well-being of CPOs.
再生医学领域正在迅速发展，获批的细胞制剂数量不断增加。然而，细胞处理设施（CPF）仍然严重依赖细胞处理操作人员（CPO）的手工操作。细胞培养的复杂性和严格的无菌要求给CPO带来了相当大的心理负担，尤其是细胞污染的风险。本研究深入探讨了CPO在细胞培养过程中与污染风险相关的心理层面。在47个地点进行了一项在线调查，以调查对污染的担忧以及在细胞处理设施中为降低污染风险而实施的策略。调查结果显示，72%的操作人员表示担心污染，18%报告有过直接的污染经历。这表明CPF中感知到的污染风险高于实际报告的事件。此外，本研究还考察了诸如物料处理等操作实践以及生物安全柜（BSC）的使用情况。结果突出了BSC使用和物料处理实践中的差异，凸显了潜在的操作挑战。在每个地点实施风险评估并利用基于证据的数据有助于应对这些挑战，减轻CPO的心理压力。反过来，这将提高细胞治疗产品的质量并改善CPO的健康状况。
