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

Stewart Abbot; Francisca Agbanyo; Jan-Eric Ahlfors; Behnam A. Baghbaderani; Shirley Bartido; Kapil Bharti; Carl Burke; Bjorn Carlsson; Joy Cavagnaro; Abla Creasey; Stephen Lin; David DiGiusto; Kathy Francissen; Andrew Gaffney; Christopher Goldring; Thorsten Gorba; Elwyn Griffiths; Anthony Lubiniecki; Joris Vandeputte; Tadaaki Hanatani; Takao Hayakawa; Tatsuo Heki; Karin Hoogendoorn; Shin Kawamata; Hironobu Kimura; Agnete Kirkeby; Ivana Knezevic; Jane Lebkowski; Shen Lin-Gibson; Orla O'Shea; Martin Pera; John Petricciani; Gary Pigeau; Anthony Ratcliffe; Yoji Sato; Gerald G. Schumann; William Shingleton; Chair Glyn Stacey; Stephen Sullivan; Clive N. Svendsen; Jean-Hugues Trouvin; Bao-Zhu Yuan; Kathryn Zoon

doi:10.1016/j.biologicals.2018.08.004

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

Stewart Abbot, Francisca Agbanyo, Jan-Eric Ahlfors, Behnam A. Baghbaderani, Shirley Bartido, Kapil Bharti, Carl Burke, Bjorn Carlsson, Joy Cavagnaro, Abla Creasey, Stephen Lin, David DiGiusto, Kathy Francissen, Andrew Gaffney, Christopher Goldring, Thorsten Gorba, Elwyn Griffiths, Anthony Lubiniecki, Joris Vandeputte, Tadaaki HanataniTakao Hayakawa, Tatsuo Heki, Karin Hoogendoorn, Shin Kawamata, Hironobu Kimura, Agnete Kirkeby, Ivana Knezevic, Jane Lebkowski, Shen Lin-Gibson, Orla O'Shea, Martin Pera, John Petricciani, Gary Pigeau, Anthony Ratcliffe, Yoji Sato, Gerald G. Schumann, William Shingleton, Chair Glyn Stacey, Stephen Sullivan, Clive N. Svendsen, Jean-Hugues Trouvin, Bao-Zhu Yuan, Kathryn Zoon

Laboratory

9 Citations (Scopus)

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 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.

Original language	English
Journal	Biologicals
Volume	63
Pages (from-to)	67-83
ISSN	1095-8320
DOIs	https://doi.org/10.1016/j.biologicals.2018.08.004
Publication status	Published - Nov 2018
Event	Manufacturing and Testing of Pluripotent Stem Cells: IABS and CIRM - Los Angeles, United States Duration: 5 Jun 2018 → 6 Jun 2018

Conference

Conference	Manufacturing and Testing of Pluripotent Stem Cells
Country/Territory	United States
City	Los Angeles
Period	05/06/2018 → 06/06/2018

Keywords

cell therapy
stem cells
transplantation

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.biologicals.2018.08.004

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Abbot, S., Agbanyo, F., Ahlfors, J-E., Baghbaderani, B. A., Bartido, S., Bharti, K., Burke, C., Carlsson, B., Cavagnaro, J., Creasey, A., Lin, S., DiGiusto, D., Francissen, K., Gaffney, A., Goldring, C., Gorba, T., Griffiths, E., Lubiniecki, A., Vandeputte, J., ... Zoon, K. (2018). Report of the international conference on manufacturing and testing of pluripotent stem cells. Biologicals, 63, 67-83. https://doi.org/10.1016/j.biologicals.2018.08.004

Abbot, S, Agbanyo, F, Ahlfors, J-E, Baghbaderani, BA, Bartido, S, Bharti, K, Burke, C, Carlsson, B, Cavagnaro, J, Creasey, A, Lin, S, DiGiusto, D, Francissen, K, Gaffney, A, Goldring, C, Gorba, T, Griffiths, E, Lubiniecki, A, Vandeputte, J, Hanatani, T, Hayakawa, T, Heki, T, Hoogendoorn, K, Kawamata, S, Kimura, H, Kirkeby, A, Knezevic, I, Lebkowski, J, Lin-Gibson, S, O'Shea, O, Pera, M, Petricciani, J, Pigeau, G, Ratcliffe, A, Sato, Y, Schumann, GG, Shingleton, W, Stacey, CG, Sullivan, S, Svendsen, CN, Trouvin, J-H, Yuan, B-Z & Zoon, K 2018, 'Report of the international conference on manufacturing and testing of pluripotent stem cells', Biologicals, vol. 63, pp. 67-83. https://doi.org/10.1016/j.biologicals.2018.08.004

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title = "Report of the international conference on manufacturing and testing of pluripotent stem cells",

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 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.",

keywords = "cell therapy, stem cells, transplantation",

author = "Stewart Abbot and Francisca Agbanyo and Jan-Eric Ahlfors and Baghbaderani, {Behnam A.} and Shirley Bartido and Kapil Bharti and Carl Burke and Bjorn Carlsson and Joy Cavagnaro and Abla Creasey and Stephen Lin and David DiGiusto and Kathy Francissen and Andrew Gaffney and Christopher Goldring and Thorsten Gorba and Elwyn Griffiths and Anthony Lubiniecki and Joris Vandeputte and Tadaaki Hanatani and Takao Hayakawa and Tatsuo Heki and Karin Hoogendoorn and Shin Kawamata and Hironobu Kimura and Agnete Kirkeby and Ivana Knezevic and Jane Lebkowski and Shen Lin-Gibson and Orla O'Shea and Martin Pera and John Petricciani and Gary Pigeau and Anthony Ratcliffe and Yoji Sato and Schumann, {Gerald G.} and William Shingleton and Stacey, {Chair Glyn} and Stephen Sullivan and Svendsen, {Clive N.} and Jean-Hugues Trouvin and Bao-Zhu Yuan and Kathryn Zoon",

note = "M1 - Copyright (C) 2018 U.S. National Library of Medicine. MEDLINE AN 2020223183(Journal; Article; (JOURNAL ARTICLE)); Manufacturing and Testing of Pluripotent Stem Cells : IABS and CIRM ; Conference date: 05-06-2018 Through 06-06-2018",

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doi = "10.1016/j.biologicals.2018.08.004",

language = "English",

volume = "63",

pages = "67--83",

journal = "Biologicals",

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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

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.

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.

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

SN - 1045-1056

VL - 63

SP - 67

EP - 83

JO - Biologicals

JF - Biologicals

T2 - Manufacturing and Testing of Pluripotent Stem Cells

Y2 - 5 June 2018 through 6 June 2018

ER -

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

Abstract

Conference

Keywords

UN SDGs

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