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Development of genetic quality tests for good manufacturing practice-compliant induced pluripotent stem cells and their derivatives

ABSTRACT: Development of genetic quality tests for good manufacturing practice-compliant induced pluripotent stem cells and their derivatives

PROVIDER: PRJNA624867 | ENA |

REPOSITORIES: ENA

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Development of genetic quality tests for good manufacturing practice-compliant induced pluripotent stem cells and their derivatives

Project description:Purpose : We investigated RNA-seq-based broad-range genetic quality tests on GMP-compliant human leucocyte antigen (HLA)-homozygous hiPSCs and their derivatives under postdistribution conditions to investigate whether sequencing data could provide a basis for future quality control. Methods : Transcriptome profiling of the differentiated cell lines in three lineages, including neuronal cells, cardiomyocytes and hepatocytes, at early and late passages, respectively, were carried out using RNA sequencing. Results : We performed SNV, indel, CNV, ekaryotyping, HLA genotyping and transcriptomic analyses in which differentiated cells were compared with hiPSCs using RNA-seq data from undifferentiated and differentiated cultures returned from multiple centres. In particular, we evaluated whether prolonged culture conditions have the potential to give rise to genomic and phenotypic changes in the CMC3 hiPSC line, a candidate line for manufacturing cell therapies. Conclusion : RNA-seq analysis appears to offer an informative genetic quality testing approach for cell types and allows the early screening of candidate hiPSC seed stocks for clinical use by facilitating safety and potential risk evaluation

2020-04-13 | GSE148517 | GEO

Development of genetic quality tests for good manufacturing practice-compliant induced pluripotent stem cells and their derivatives.

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Comprehensive analysis of the secretome and transcriptome stability from WJ-Mesenchymal Stromal cells throughout GMP-Manufacturing

Project description:Mesenchymal stromal cells (MSCs) hold promise for cell-based therapies due to their ability to stimulate tissue repair and modulate immune responses. Umbilical cord-derived MSC from Wharton’s jelly (WJ), offer advantages such as low immunogenicity and potent immune modulatory effects. However, ensuring consistent quality and safety throughout their manufacturing process remains critical. RNA sequencing (RNA-seq) emerges as a crucial tool for assessing genetic stability and expression dynamics. This study examines the secretome and transcriptome signatures throughout WJ-MSCs Good Manufacturing Practice (GMP) production, focusing in the role of Total RNA or Massive Analysis of cDNA Ends (MACE-Seq)-RNA sequencing. Through comprehensive transcriptomic analysis, we demonstrated the stability of WJ-MSC transcriptome across manufacturing stages. Notably, MACE-Seq enhanced the identification of key expression patterns related to senescence and immunomodulation. These findings highlight the potential of MACE-Seq as a routine quality assessment tool for WJ-MSC-based therapies, ensuring their efficacy and safety in clinical applications. Importantly, MACE-Seq proves valuable for characterizing WJ-MSC products, providing insights unattainable through traditional assays.

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Project description:Cell replacement therapies for Parkinson’s Disease (PD) based on transplantation of dopaminergic neurons generated from pluripotent stem cell sources are now entering clinical trials. Here, we present the quality, safety and efficacy data supporting a first-in-human clinical trial in PD using an embryonic stem cell product STEM-PD, as well as the design of the trial itself. The cryopreserved STEM-PD product was manufactured under Good Manufacturing Practice (GMP) and fully quality-tested in vitro for regulatory compliance. The product was further tested in an extensive 39-week Good Laboratory Practice (GLP) safety study in immunodeficient rats for toxicity, tumourigenicity and biodistribution, as well as in a 24-week non-GLP efficacy study. These studies showed that the transplanted STEM-PD cells could induce full functional recovery in a pre-clinical rat model of PD, and that the treatment did not give rise to any adverse effects. This cell batch will be used for all participants in the STEM-PD Phase I/IIa clinical trial, where the first of 8 patients with moderate PD have now been transplanted. Furthermore, we observed highly comparable in vivo efficacy results between two different GMP batches of STEM-PD cells, verifying that this product has the potential to be serially manufactured for widespread clinical use.

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Preclinical quality, safety and efficacy of a human embryonic stem cell-derived product for treatment of people with moderate Parkinson’s Disease (STEM-PD) I

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