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  • Abbot, StewartFate Therapeutics (author)

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

  • Article/chapterEnglish2018

Publisher, publication year, extent ...

  • Elsevier BV,2018

Numbers

  • LIBRIS-ID:oai:lup.lub.lu.se:e3bdd572-6af7-4483-9cae-5e9fe5f8c956
  • https://lup.lub.lu.se/record/e3bdd572-6af7-4483-9cae-5e9fe5f8c956URI
  • https://doi.org/10.1016/j.biologicals.2018.08.004DOI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:art swepub-publicationtype
  • Subject category:vet swepub-contenttype

Notes

  • 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 and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Agbanyo, FranciscaPublic Health Agency of Canada (author)
  • Ahlfors, Jan EricFortuna Fix (author)
  • Baghbaderani, Behnam A.Lonza, Inc. USA (author)
  • Bartido, ShirleyCellectis Inc. (author)
  • Bharti, KapilNational Institutes of Health, United States (author)
  • Burke, CarlJanssen Pharmaceuticals, US (author)
  • Carlsson, BjornSwedish medical products agency (author)
  • Cavagnaro, JoyAccess Bio Inc. (author)
  • Creasey, AblaCalifornia Institute for Regenerative Medicine (CIRM) (author)
  • DiGiusto, DavidStanford University School of Medicine (author)
  • Francissen, KathyGenentech, Inc (author)
  • Gaffney, AndrewSTEMCELL Technologies Inc. (author)
  • Goldring, ChristopherUniversity of Liverpool (author)
  • Gorba, ThorstenIQVIA Inc. (author)
  • Griffiths, ElwynInternational Alliance for Biological Standardization (IABS) (author)
  • Hanatani, TadaakiKyoto University (author)
  • Hayakawa, TakaoOsaka University (author)
  • Heki, TatsuoFujifilm (author)
  • Hoogendoorn, KarinLeiden University Medical Centre (author)
  • Kawamata, ShinFoundation for Biomedical Research and Innovation (FBRI) (author)
  • Kimura, HironobuHealios K.K. (author)
  • Kirkeby, AgneteLund University,Lunds universitet,Human neural utvecklingsbiologi,Forskargrupper vid Lunds universitet,Human Neural Developmental Biology,Lund University Research Groups,University of Copenhagen(Swepub:lu)med-agk (author)
  • Knezevic, IvanaWorld Health Organization (WHO) (author)
  • Lebkowski, JaneRegenerative Patch Technologies Inc. (author)
  • Lin, StephenCalifornia Institute for Regenerative Medicine (CIRM) (author)
  • Lin-Gibson, ShenNational Institute of Standards and Technology (NIST) (author)
  • Lubiniecki, AnthonyInternational Alliance for Biological Standardization (IABS) (author)
  • O'Shea, OrlaNational Institute for Biological Standards and Control (author)
  • Pera, MartinThe Jackson Laboratory (author)
  • Petricciani, JohnInternational Alliance for Biological Standardization (IABS) (author)
  • Pigeau, GaryCentre for Commercialization of Regenerative Medicine (CCRM) (author)
  • Ratcliffe, AnthonyThe Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery (SCB) (author)
  • Sato, YojiNational Institute of Health Sciences (NIHS), Japan (author)
  • Schumann, Gerald G.Paul Ehrlich Institute (author)
  • Shingleton, WilliamGE Healthcare, UK (author)
  • Stacey (Chair), GlynUniversity of Liverpool (author)
  • Sullivan, StephenGlobal Alliance for IPSC Therapies (GAiT) (author)
  • Svendsen, Clive N.Cedars-Sinai Medical Center (author)
  • Trouvin, Jean HuguesParis Descartes University (author)
  • Vandeputte, JorisInternational Alliance for Biological Standardization (IABS) (author)
  • Yuan, Bao ZhuNational Institutes for Food and Drug Control (NIFDC) (author)
  • Zoon, KathrynNational Institutes of Health, United States (author)
  • Fate TherapeuticsPublic Health Agency of Canada (creator_code:org_t)

Related titles

  • In:Biologicals: Elsevier BV56, s. 67-831045-1056

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