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

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.