Report of the international conference on manufacturing and testing of pluripotent stem cells
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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; Creasey, Abla; Lin, Stephen; DiGiusto, David; Francissen, Kathy; Gaffney, Andrew; Goldring, Christopher; Gorba, Thorsten; Griffiths, Elwyn; Lubiniecki, Anthony; Vandeputte, Joris; Hanatani, Tadaaki; Hayakawa, Takao; Heki, Tatsuo; Hoogendoorn, Karin; Kawamata, Shin; Kimura, Hironobu; Kirkeby, Agnete; Knezevic, Ivana; Lebkowski, Jane; Lin-Gibson, Shen; 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; Yuan, Bao-Zhu; Zoon, Kathryn.
In: Biologicals, Vol. 63, 11.2018, p. 67-83.Research output: Contribution to journal › Conference article › Research › peer-review
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TY - GEN
T1 - Report of the international conference on manufacturing and testing of pluripotent stem cells
AU - Abbot, Stewart
AU - Agbanyo, Francisca
AU - Ahlfors, Jan-Eric
AU - Baghbaderani, Behnam A.
AU - Bartido, Shirley
AU - Bharti, Kapil
AU - Burke, Carl
AU - Carlsson, Bjorn
AU - Cavagnaro, Joy
AU - Creasey, Abla
AU - Lin, Stephen
AU - DiGiusto, David
AU - Francissen, Kathy
AU - Gaffney, Andrew
AU - Goldring, Christopher
AU - Gorba, Thorsten
AU - Griffiths, Elwyn
AU - Lubiniecki, Anthony
AU - Vandeputte, Joris
AU - Hanatani, Tadaaki
AU - Hayakawa, Takao
AU - Heki, Tatsuo
AU - Hoogendoorn, Karin
AU - Kawamata, Shin
AU - Kimura, Hironobu
AU - Kirkeby, Agnete
AU - Knezevic, Ivana
AU - Lebkowski, Jane
AU - Lin-Gibson, Shen
AU - O'Shea, Orla
AU - Pera, Martin
AU - Petricciani, John
AU - Pigeau, Gary
AU - Ratcliffe, Anthony
AU - Sato, Yoji
AU - Schumann, Gerald G.
AU - Shingleton, William
AU - Stacey, Chair Glyn
AU - Sullivan, Stephen
AU - Svendsen, Clive N.
AU - Trouvin, Jean-Hugues
AU - Yuan, Bao-Zhu
AU - Zoon, Kathryn
N1 - M1 - Copyright (C) 2018 U.S. National Library of Medicine. MEDLINE AN 2020223183(Journal; Article; (JOURNAL ARTICLE))
PY - 2018/11
Y1 - 2018/11
N2 - 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.[on SciFinder (R)]
AB - 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.[on SciFinder (R)]
KW - cell therapy
KW - stem cells
KW - transplantation
U2 - 10.1016/j.biologicals.2018.08.004
DO - 10.1016/j.biologicals.2018.08.004
M3 - Conference article
C2 - 30150108
VL - 63
SP - 67
EP - 83
JO - Biologicals
JF - Biologicals
SN - 1045-1056
T2 - Manufacturing and Testing of Pluripotent Stem Cells
Y2 - 5 June 2018 through 6 June 2018
ER -
ID: 202078718