GMP-compatible manufacturing of three iPS cell lines from human peripheral blood

Alexandra Haase; Wolfgang Glienke; Lena Engels; Gudrun Göhring; Ruth Esser; Lubomir Arseniev; Ulrich Martin

Stem Cell Research (Mar 2019)

GMP-compatible manufacturing of three iPS cell lines from human peripheral blood

Alexandra Haase,
Wolfgang Glienke,
Lena Engels,
Gudrun Göhring,
Ruth Esser,
Lubomir Arseniev,
Ulrich Martin

Affiliations

Alexandra Haase: Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO), REBIRTH Cluster of Excellence, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany; Corresponding author.
Wolfgang Glienke: GMP Development Unit, Institute of Cellular Therapeutics, Integrated Research and Treatment Center, Hannover Medical School, Germany
Lena Engels: Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO), REBIRTH Cluster of Excellence, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
Gudrun Göhring: Institute for Human Genetics, Hannover Medical School, Germany
Ruth Esser: GMP Development Unit, Institute of Cellular Therapeutics, Integrated Research and Treatment Center, Hannover Medical School, Germany
Lubomir Arseniev: GMP Development Unit, Institute of Cellular Therapeutics, Integrated Research and Treatment Center, Hannover Medical School, Germany
Ulrich Martin: Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO), REBIRTH Cluster of Excellence, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany

Journal volume & issue: Vol. 35

Abstract

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The utilization of human induced pluripotent stem cells (hiPSCs) for disease modeling and drug discovery is already reality, and several first-in-man-applications as cellular therapeutics have been initiated. Implementation of good manufacturing practice (GMP)-compliant protocols for the generation of hiPSC lines is crucial to increase the application safety as well as to fulfil the legal requirements for clinical trials approval. Here we describe the development of a GMP-compatible protocol for the reprogramming of CD34+ hematopoietic stem cells from peripheral blood (CD34+ PBHSC) into hiPSCs using Sendai virus-based reprogramming vectors. Three GMP-compatible hiPSC (GMP-hiPSC) lines were manufactured and characterized under these conditions.

Published in Stem Cell Research

ISSN: 1873-5061 (Print); 1876-7753 (Online)
Publisher: Elsevier
Country of publisher: Netherlands
LCC subjects: Science: Biology (General)
Website: https://www.journals.elsevier.com/stem-cell-research

About the journal