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

Journal: 
Biologicals
Publication Year: 
2018
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
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
PubMed link: 
30150108
Public Summary: 
International Alliance for Biological Standardization (IABS) sponsored a public scientific meeting on cell therapy which was generously supported by the California Institute for Regenerative Medicine (CIRM). Sessions included an overview of past cell therapy (CT) conferences sponsored by the International Alliance for Biological Standardization. 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 CIRM will explore with stakeholders the development of a practical and innovative road map to support early CT product (CTP) developers.
Scientific 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.