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

Abbot, Stewart (author)
Fate Therapeutics
Agbanyo, Francisca (author)
Public Health Agency of Canada
Ahlfors, Jan Eric (author)
Fortuna Fix
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Baghbaderani, Behnam A. (author)
Lonza, Inc. USA
Bartido, Shirley (author)
Cellectis Inc.
Bharti, Kapil (author)
National Institutes of Health, United States
Burke, Carl (author)
Janssen Pharmaceuticals, US
Carlsson, Bjorn (author)
Swedish medical products agency
Cavagnaro, Joy (author)
Access Bio Inc.
Creasey, Abla (author)
California Institute for Regenerative Medicine (CIRM)
DiGiusto, David (author)
Stanford University School of Medicine
Francissen, Kathy (author)
Genentech, Inc
Gaffney, Andrew (author)
STEMCELL Technologies Inc.
Goldring, Christopher (author)
University of Liverpool
Gorba, Thorsten (author)
IQVIA Inc.
Griffiths, Elwyn (author)
International Alliance for Biological Standardization (IABS)
Hanatani, Tadaaki (author)
Kyoto University
Hayakawa, Takao (author)
Osaka University
Heki, Tatsuo (author)
Fujifilm
Hoogendoorn, Karin (author)
Leiden University Medical Centre
Kawamata, Shin (author)
Foundation for Biomedical Research and Innovation (FBRI)
Kimura, Hironobu (author)
Healios K.K.
Kirkeby, Agnete (author)
Lund University,Lunds universitet,Human neural utvecklingsbiologi,Forskargrupper vid Lunds universitet,Human Neural Developmental Biology,Lund University Research Groups,University of Copenhagen
Knezevic, Ivana (author)
World Health Organization (WHO)
Lebkowski, Jane (author)
Regenerative Patch Technologies Inc.
Lin, Stephen (author)
California Institute for Regenerative Medicine (CIRM)
Lin-Gibson, Shen (author)
National Institute of Standards and Technology (NIST)
Lubiniecki, Anthony (author)
International Alliance for Biological Standardization (IABS)
O'Shea, Orla (author)
National Institute for Biological Standards and Control
Pera, Martin (author)
The Jackson Laboratory
Petricciani, John (author)
International Alliance for Biological Standardization (IABS)
Pigeau, Gary (author)
Centre for Commercialization of Regenerative Medicine (CCRM)
Ratcliffe, Anthony (author)
The Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery (SCB)
Sato, Yoji (author)
National Institute of Health Sciences (NIHS), Japan
Schumann, Gerald G. (author)
Paul Ehrlich Institute
Shingleton, William (author)
GE Healthcare, UK
Stacey (Chair), Glyn (author)
University of Liverpool
Sullivan, Stephen (author)
Global Alliance for IPSC Therapies (GAiT)
Svendsen, Clive N. (author)
Cedars-Sinai Medical Center
Trouvin, Jean Hugues (author)
Paris Descartes University
Vandeputte, Joris (author)
International Alliance for Biological Standardization (IABS)
Yuan, Bao Zhu (author)
National Institutes for Food and Drug Control (NIFDC)
Zoon, Kathryn (author)
National Institutes of Health, United States
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 (creator_code:org_t)
Elsevier BV, 2018
2018
English.
In: Biologicals. - : Elsevier BV. - 1045-1056. ; 56, s. 67-83
  • Journal article (other academic/artistic)
Abstract Subject headings
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  • 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.

Subject headings

NATURVETENSKAP  -- Biologi -- Cellbiologi (hsv//swe)
NATURAL SCIENCES  -- Biological Sciences -- Cell Biology (hsv//eng)

Keyword

Cell therapy
Stem cells
Transplantation

Publication and Content Type

art (subject category)
vet (subject category)

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