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; David DiGiusto; Kathy Francissen; Andrew Gaffney; Christopher Goldring; Thorsten Gorba; Elwyn Griffiths; Tadaaki Hanatani; Takao Hayakawa; Tatsuo Heki; Karin Hoogendoorn; Shin Kawamata; Hironobu Kimura; Agnete Kirkeby; Ivana Knezevic; Jane Lebkowski; Stephen Lin; Shen Lin-Gibson; Anthony Lubiniecki; Orla O'Shea; Martin Pera; John Petricciani; Gary Pigeau; Anthony Ratcliffe; Yoji Sato; Gerald G. Schumann; William Shingleton; Glyn Stacey (Chair); Stephen Sullivan; Clive N. Svendsen; Jean Hugues Trouvin; Joris Vandeputte; 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, David DiGiusto, Kathy Francissen, Andrew Gaffney, Christopher Goldring, Thorsten Gorba, Elwyn Griffiths, Tadaaki Hanatani, Takao Hayakawa, Tatsuo Heki, Karin HoogendoornShin Kawamata, Hironobu Kimura, Agnete Kirkeby, Ivana Knezevic, Jane Lebkowski, Stephen Lin, Shen Lin-Gibson, Anthony Lubiniecki, Orla O'Shea, Martin Pera, John Petricciani, Gary Pigeau, Anthony Ratcliffe, Yoji Sato, Gerald G. Schumann, William Shingleton, Glyn Stacey (Chair), Stephen Sullivan, Clive N. Svendsen, Jean Hugues Trouvin, Joris Vandeputte, Bao Zhu Yuan, Kathryn Zoon

Research output: Contribution to journal › Debate/Note/Editorial

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
Pages (from-to)	67-83
Journal	Biologicals
Volume	56
DOIs	https://doi.org/10.1016/j.biologicals.2018.08.004
Publication status	Published - 2018

Subject classification (UKÄ)

Cell Biology

Free 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., DiGiusto, D., Francissen, K., Gaffney, A., Goldring, C., Gorba, T., Griffiths, E., Hanatani, T., Hayakawa, T., Heki, T., ... Zoon, K. (2018). Report of the international conference on manufacturing and testing of pluripotent stem cells. Biologicals, 56, 67-83. https://doi.org/10.1016/j.biologicals.2018.08.004

@article{e3bdd5726af744839cae5e9fe5f8c956,

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 Ahlfors, {Jan Eric} and Baghbaderani, {Behnam A.} and Shirley Bartido and Kapil Bharti and Carl Burke and Bjorn Carlsson and Joy Cavagnaro and Abla Creasey and David DiGiusto and Kathy Francissen and Andrew Gaffney and Christopher Goldring and Thorsten Gorba and Elwyn Griffiths 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 Stephen Lin and Shen Lin-Gibson and Anthony Lubiniecki 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 Trouvin, {Jean Hugues} and Joris Vandeputte and Yuan, {Bao Zhu} and Kathryn Zoon",

year = "2018",

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

language = "English",

volume = "56",

pages = "67--83",

journal = "Biologicals",

issn = "1045-1056",

publisher = "Academic Press",

}

Abbot, S, Agbanyo, F, Ahlfors, JE, Baghbaderani, BA, Bartido, S, Bharti, K, Burke, C, Carlsson, B, Cavagnaro, J, Creasey, A, DiGiusto, D, Francissen, K, Gaffney, A, Goldring, C, Gorba, T, Griffiths, E, Hanatani, T, Hayakawa, T, Heki, T, Hoogendoorn, K, Kawamata, S, Kimura, H, Kirkeby, A, Knezevic, I, Lebkowski, J, Lin, S, Lin-Gibson, S, Lubiniecki, A, O'Shea, O, Pera, M, Petricciani, J, Pigeau, G, Ratcliffe, A, Sato, Y, Schumann, GG, Shingleton, W, Stacey (Chair), G, Sullivan, S, Svendsen, CN, Trouvin, JH, Vandeputte, J, Yuan, BZ & Zoon, K 2018, 'Report of the international conference on manufacturing and testing of pluripotent stem cells', Biologicals, vol. 56, pp. 67-83. https://doi.org/10.1016/j.biologicals.2018.08.004

TY - JOUR

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 - DiGiusto, David

AU - Francissen, Kathy

AU - Gaffney, Andrew

AU - Goldring, Christopher

AU - Gorba, Thorsten

AU - Griffiths, Elwyn

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, Stephen

AU - Lin-Gibson, Shen

AU - Lubiniecki, Anthony

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 - Vandeputte, Joris

AU - Yuan, Bao Zhu

AU - Zoon, Kathryn

PY - 2018

Y1 - 2018

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 - Debate/Note/Editorial

C2 - 30150108

AN - SCOPUS:85054421442

SN - 1045-1056

VL - 56

SP - 67

EP - 83

JO - Biologicals

JF - Biologicals

ER -

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

Abstract

Subject classification (UKÄ)

Free keywords

UN SDGs

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