Mizutani Manabu, Terunuma Hiroshi, Samejima Hazuki, Ashiba Keisuke, Kino-Oka Masahiro
Division of Science and Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan.
Biotherapy Institute of Japan, 2-4-8 Edagawa, Koto-ku, Tokyo 135-0051, Japan.
Regen Ther. 2019 Apr 27;12:102-107. doi: 10.1016/j.reth.2019.04.005. eCollection 2019 Dec 15.
To prepare an autologous cell-based product in a cell processing facility, the raw material, which is collected from a patient, must first be shipped from a medical institution to the facility. The quality of this raw material varies depending on the patient, and variations due to transport methods also occur. Because the quality must be uniform and manufacturing processes need to be adjusted to account for these variations, determining the effect of shipment conditions on raw materials is very important for estimating cell manufacturability in the process design. In this study, a group of medical institutions located in different areas requested similar cell-based products processed by the same manufacturing method to a company that is licensed under the Act on the Safety of Regenerative Medicine in Japan. Manufacturing reproducibility was analyzed based on 456 cell batches received from two clinics that were processed used the same manufacturing method. The specific growth rates that were observed in the early growth phase supposed that the proliferative potential of the primary cells in the raw material was influenced by transit time. Simultaneously, the variation of the specific growth rates in the late phase were supposed to be hardly occurred. Thus, this study evaluated shipping conditions of the raw materials for an autologous cell-based product, and a strategy for verifying the influence of transportation on quality in manufacturing was suggested.
要在细胞处理设施中制备基于自体细胞的产品，首先必须将从患者身上采集的原材料从医疗机构运送到该设施。这种原材料的质量因患者而异，并且由于运输方式不同也会出现差异。由于质量必须统一，且制造工艺需要根据这些差异进行调整，因此在工艺设计中确定运输条件对原材料的影响对于评估细胞可制造性非常重要。在本研究中，位于不同地区的一组医疗机构向一家根据日本《再生医学安全法》获得许可的公司请求采用相同制造方法处理类似的基于细胞的产品。基于从两家诊所接收的456个细胞批次（采用相同制造方法进行处理）分析了制造再现性。在早期生长阶段观察到的比生长速率表明，原材料中原代细胞的增殖潜力受运输时间影响。同时，后期比生长速率的变化应该很少发生。因此，本研究评估了基于自体细胞产品的原材料运输条件，并提出了一种在制造过程中验证运输对质量影响的策略。
