Your browser doesn't support javascript.
loading
Report of the international conference on manufacturing and testing of pluripotent stem cells.
Abbot, Stewart; Agbanyo, Francisca; Ahlfors, Jan-Eric; Baghbaderani, Behnam A; Bartido, Shirley; Bharti, Kapil; Burke, Carl; Carlsson, Bjorn; Cavagnaro, Joy; Creasey, Abla; DiGiusto, David; Francissen, Kathy; Gaffney, Andrew; Goldring, Christopher; Gorba, Thorsten; Griffiths, Elwyn; Hanatani, Tadaaki; Hayakawa, Takao; Heki, Tatsuo; Hoogendoorn, Karin; Kawamata, Shin; Kimura, Hironobu; Kirkeby, Agnete; Knezevic, Ivana; Lebkowski, Jane; Lin, Stephen; Lin-Gibson, Shen; Lubiniecki, Anthony; O'Shea, Orla; Pera, Martin; Petricciani, John; Pigeau, Gary; Ratcliffe, Anthony; Sato, Yoji; Schumann, Gerald G; Shingleton, William; Stacey Chair, Glyn; Sullivan, Stephen; Svendsen, Clive N; Trouvin, Jean-Hugues; Vandeputte, Joris; Yuan, Bao-Zhu; Zoon, Kathryn.
Afiliación
  • Abbot S; Fate Therapeutics, USA.
  • Agbanyo F; Health Canada, Canada.
  • Ahlfors JE; Fortuna Fix, Canada.
  • Baghbaderani BA; Lonza, Emerging Technologies, USA.
  • Bartido S; Cellectis, USA.
  • Bharti K; National Institutes of Health (NIH), USA.
  • Burke C; Janssen Pharmaceuticals, USA.
  • Carlsson B; Medical Products Agency, Sweden.
  • Cavagnaro J; Access BIO, USA.
  • Creasey A; California Institute for Regenerative Medicine (CIRM), USA.
  • DiGiusto D; Stanford University School of Medicine, USA.
  • Francissen K; Genentech, USA.
  • Gaffney A; STEMCELL Technologies, Canada.
  • Goldring C; University of Liverpool, UK.
  • Gorba T; IQVIA, USA.
  • Griffiths E; International Alliance for Biological Standardization (lABS), Switzerland.
  • Hanatani T; Kyoto University, Japan.
  • Hayakawa T; Osaka University, Japan, Kindai University, Japan.
  • Heki T; Fujifilm, Japan.
  • Hoogendoorn K; Leiden University Medical Center, the Netherlands.
  • Kawamata S; Foundation for Biomedical Research and Innovation (FBRI), Japan.
  • Kimura H; HEALIOS K.K., Japan.
  • Kirkeby A; University of Lund, Sweden and University of Copenhagen, Denmark.
  • Knezevic I; World Health Organisation (WHO), Switzerland.
  • Lebkowski J; Regenerative Patch Technologies, USA.
  • Lin S; California Institute for Regenerative Medicine (CIRM), USA.
  • Lin-Gibson S; National Institute of Standards and Technology, USA.
  • Lubiniecki A; International Alliance for Biological Standardization (lABS), Switzerland.
  • O'Shea O; National Institute for Biological Standards and Control (NIBSC), UK.
  • Pera M; International Stem Cell Initiative, Jackson Laboratories, USA.
  • Petricciani J; International Alliance for Biological Standardization (lABS), Switzerland. Electronic address: jpmdpsca@aol.com.
  • Pigeau G; Centre for Commercialization of Regenerative Medicine (CCRM), Canada.
  • Ratcliffe A; Standard Coordinating Body, USA.
  • Sato Y; National Institute of Health Sciences, Japan.
  • Schumann GG; Paul-Ehrlich-Institute, Germany.
  • Shingleton W; GE Healthcare, UK.
  • Stacey Chair G; University of Liverpool, UK; International Stem Cell Banking Initiative (ISCBI), UK.
  • Sullivan S; Global Alliance for IPSC Therapies (GAiT), UK.
  • Svendsen CN; Cedars-Sinai Medical Center, USA.
  • Trouvin JH; Paris Descartes University, France.
  • Vandeputte J; International Alliance for Biological Standardization (lABS), Switzerland.
  • Yuan BZ; National Institutes for Food and Drug Control, China.
  • Zoon K; National Institutes of Health (NIH), Emerita, USA.
Biologicals ; 56: 67-83, 2018 Nov.
Article en En | MEDLINE | ID: mdl-30150108
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.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Células Madre Pluripotentes / Tratamiento Basado en Trasplante de Células y Tejidos Tipo de estudio: Guideline / Qualitative_research Límite: Humans Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Células Madre Pluripotentes / Tratamiento Basado en Trasplante de Células y Tejidos Tipo de estudio: Guideline / Qualitative_research Límite: Humans Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido