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Stem Cell Res. 2019 Mar;35:101394. doi: 10.1016/j.scr.2019.101394. Epub 2019 Feb 11.

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

Author information

1
Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO), REBIRTH Cluster of Excellence, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany. Electronic address: haase.alexandra@mh-hannover.de.
2
GMP Development Unit, Institute of Cellular Therapeutics, Integrated Research and Treatment Center, Hannover Medical School, Germany.
3
Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO), REBIRTH Cluster of Excellence, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
4
Institute for Human Genetics, Hannover Medical School, Germany.

Abstract

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.

PMID:
30772682
DOI:
10.1016/j.scr.2019.101394
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