Abstract
mRNA-electroporated dendritic cells (DC) are demonstrating clinical benefit in patients in many therapeutic areas, including cancer and infectious diseases. According to current good manufacturing guidelines, cell-based medicinal products have to be defined for identity, purity, potency, stability, and viability. In order to comply with the directives and guidelines defined by the regulatory authorities, we report here a standardized and reproducible method for the manufacturing of clinical-grade mRNA-transfected DC.
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Acknowledgments
This work was supported by positive discussion through A FACTT network (Cost Action BM1305: www.afactt.eu). COST is supported by the EU Framework Programme Horizon 2020. Further support was provided by an applied biomedical research project of the Institute for the Promotion of Innovation by Science and Technology in Flanders (IWT-TBM 140191) the Special Research Fund (BOF) from the University of Antwerp, a BOF-GOA grant (ID PS 28313), Medical Legacy Fund (UZA) and the Methusalem Funding Program. Judith Derdelinckx holds a PhD Fellowship of the Research Foundation - Flanders.
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Derdelinckx, J., Berneman, Z.N., Cools, N. (2016). GMP-Grade mRNA Electroporation of Dendritic Cells for Clinical Use. In: Rhoads, R. (eds) Synthetic mRNA. Methods in Molecular Biology, vol 1428. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-3625-0_9
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DOI: https://doi.org/10.1007/978-1-4939-3625-0_9
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Publisher Name: Humana Press, New York, NY
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Online ISBN: 978-1-4939-3625-0
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