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

Research output: Contribution to journalDebate/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.

Details

Authors
  • 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
  • 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
Organisations
External organisations
  • Janssen Research & Development LLC
  • Swedish medical products agency
  • Stanford University School of Medicine
  • Genentech, Inc
  • University of Liverpool
  • Kyoto University
  • Osaka University
  • Leiden University Medical Centre
  • National Institute for Biological Standards and Control
  • Paul Ehrlich Institute
  • Cedars-Sinai Medical Center
  • Paris Descartes University
  • Fate Therapeutics
  • Public Health Agency of Canada
  • Fortuna Fix
  • Lonza, Inc. USA
  • Cellectis Inc.
  • National Institutes of Health, United States
  • Access Bio Inc.
  • California Institute for Regenerative Medicine (CIRM)
  • STEMCELL Technologies Inc.
  • IQVIA Inc.
  • International Alliance for Biological Standardization (IABS)
  • Fujifilm
  • Foundation for Biomedical Research and Innovation (FBRI)
  • Healios K.K.
  • University of Copenhagen
  • World Health Organization (WHO)
  • Regenerative Patch Technologies Inc.
  • National Institute of Standards and Technology (NIST)
  • The Jackson Laboratory
  • Centre for Commercialization of Regenerative Medicine (CCRM)
  • The Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery (SCB)
  • National Institute of Health Sciences (NIHS), Japan
  • GE Healthcare, UK
  • Global Alliance for IPSC Therapies (GAiT)
  • National Institutes for Food and Drug Control (NIFDC)
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cell Biology

Keywords

  • Cell therapy, Stem cells, Transplantation
Original languageEnglish
Pages (from-to)67-83
JournalBiologicals
Volume56
Publication statusPublished - 2018
Publication categoryResearch
Peer-reviewedNo