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Report of the international conference on manufacturing and testing of pluripotent stem cells

Abbot, Stewart; Agbanyo, Francisca; Ahlfors, Jan Eric; Baghbaderani, Behnam A.; Bartido, Shirley; Bharti, Kapil; Burke, Carl; Carlsson, Bjorn; Cavagnaro, Joy and Creasey, Abla, et al. (2018) In Biologicals 56. p.67-83
Abstract

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... (More)

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.

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@misc{e3bdd572-6af7-4483-9cae-5e9fe5f8c956,
  abstract     = {<p>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.</p>},
  author       = {Abbot, Stewart and Agbanyo, Francisca and Ahlfors, Jan Eric and Baghbaderani, Behnam A. and Bartido, Shirley and Bharti, Kapil and Burke, Carl and Carlsson, Bjorn and Cavagnaro, Joy and Creasey, Abla and DiGiusto, David and Francissen, Kathy and Gaffney, Andrew and Goldring, Christopher and Gorba, Thorsten and Griffiths, Elwyn and Hanatani, Tadaaki and Hayakawa, Takao and Heki, Tatsuo and Hoogendoorn, Karin and Kawamata, Shin and Kimura, Hironobu and Kirkeby, Agnete and Knezevic, Ivana and Lebkowski, Jane and Lin, Stephen and Lin-Gibson, Shen and Lubiniecki, Anthony and O'Shea, Orla and Pera, Martin and Petricciani, John and Pigeau, Gary and Ratcliffe, Anthony and Sato, Yoji and Schumann, Gerald G. and Shingleton, William and Stacey (Chair), Glyn and Sullivan, Stephen and Svendsen, Clive N. and Trouvin, Jean Hugues and Vandeputte, Joris and Yuan, Bao Zhu and Zoon, Kathryn},
  issn         = {1045-1056},
  keyword      = {Cell therapy,Stem cells,Transplantation},
  language     = {eng},
  month        = {08},
  pages        = {67--83},
  series       = {Biologicals},
  title        = {Report of the international conference on manufacturing and testing of pluripotent stem cells},
  url          = {http://dx.doi.org/10.1016/j.biologicals.2018.08.004},
  volume       = {56},
  year         = {2018},
}