Abbot Stewart, Agbanyo Francisca, Ahlfors Jan-Eric, Baghbaderani Behnam A, Bartido Shirley, Bharti Kapil, Burke Carl, Carlsson Bjorn, Cavagnaro Joy, Creasey Abla, DiGiusto David, Francissen Kathy, Gaffney Andrew, Goldring Christopher, Gorba Thorsten, Griffiths Elwyn, Hanatani Tadaaki, Hayakawa Takao, Heki Tatsuo, Hoogendoorn Karin, Kawamata Shin, Kimura Hironobu, Kirkeby Agnete, Knezevic Ivana, Lebkowski Jane, Lin Stephen, Lin-Gibson Shen, Lubiniecki Anthony, O'Shea Orla, Pera Martin, Petricciani John, Pigeau Gary, Ratcliffe Anthony, Sato Yoji, Schumann Gerald G, Shingleton William, Stacey Chair Glyn, Sullivan Stephen, Svendsen Clive N, Trouvin Jean-Hugues, Vandeputte Joris, Yuan Bao-Zhu, Zoon Kathryn
Fate Therapeutics, USA.
Health Canada, Canada.
Biologicals. 2018 Nov;56:67-83. doi: 10.1016/j.biologicals.2018.08.004. Epub 2018 Aug 24.
Sessions included an overview of past cell therapy (CT) conferences sponsored by the International Alliance for Biological Standardization (IABS). The sessions highlighted challenges in the field of human pluripotent stem cells (hPSCs) and also addressed specific points on manufacturing, bioanalytics and comparability, tumorigenicity testing, storage, and shipping. Panel discussions complemented the presentations. The conference concluded that a range of new standardization groups is emerging that could help the field, but ways must be found to ensure that these efforts are coordinated. In addition, there are opportunities for regulatory convergence starting with a gap analysis of existing guidelines to determine what might be missing and what issues might be creating divergence. More specific global regulatory guidance, preferably from WHO, would be welcome. IABS and the California Institute for Regenerative Medicine (CIRM) will explore with stakeholders the development of a practical and innovative road map to support early CT product (CTP) developers.
会议内容包括对国际生物标准化联盟（IABS）主办的过往细胞治疗（CT）会议的概述。会议强调了人类多能干细胞（hPSC）领域的挑战，还讨论了制造、生物分析与可比性、致瘤性测试、储存及运输等方面的具体要点。小组讨论对演讲内容起到了补充作用。会议得出结论，一系列新的标准化组织正在涌现，这可能会对该领域有所帮助，但必须找到方法确保这些努力能够协调一致。此外，从对现有指南进行差距分析以确定可能缺失的内容以及可能导致分歧的问题入手，存在监管趋同的机会。更具体的全球监管指南，最好是来自世界卫生组织的，将是受欢迎的。IABS和加利福尼亚再生医学研究所（CIRM）将与利益相关者探讨制定一份实用且创新的路线图，以支持早期细胞治疗产品（CTP）开发者。
