Process analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMP

Abstract Quality, traceability and reproducibility are crucial factors in the reliable manufacture of cellular therapeutics, as part of the overall framework of Good Manufacturing Practice (GMP). As more and more cellular therapeutics progress towards the clinic and research protocols are adapted to...

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Autores principales:	Moyra Lawrence, Amanda Evans, Thomas Moreau, Marta Bagnati, Matthew Smart, Enas Hassan, Jahid Hasan, Monica Pianella, Julie Kerby, Cedric Ghevaert
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/ec9c921fb0fa4a27a26eb34ffe692aee
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spelling	oai:doaj.org-article:ec9c921fb0fa4a27a26eb34ffe692aee2021-12-02T15:49:34ZProcess analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMP10.1038/s41536-021-00138-y2057-3995https://doaj.org/article/ec9c921fb0fa4a27a26eb34ffe692aee2021-05-01T00:00:00Zhttps://doi.org/10.1038/s41536-021-00138-yhttps://doaj.org/toc/2057-3995Abstract Quality, traceability and reproducibility are crucial factors in the reliable manufacture of cellular therapeutics, as part of the overall framework of Good Manufacturing Practice (GMP). As more and more cellular therapeutics progress towards the clinic and research protocols are adapted to comply with GMP standards, guidelines for safe and efficient adaptation have become increasingly relevant. In this paper, we describe the process analysis of megakaryocyte manufacture from induced pluripotent stem cells with a view to manufacturing in vitro platelets to European GMP for transfusion. This process analysis has allowed us an overview of the entire manufacturing process, enabling us to pinpoint the cause and severity of critical risks. Risk mitigations were then proposed for each risk, designed to be GMP compliant. These mitigations will be key in advancing this iPS-derived therapy towards the clinic and have broad applicability to other iPS-derived cellular therapeutics, many of which are currently advancing towards GMP-compliance. Taking these factors into account during protocol design could potentially save time and money, expediting the advent of safe, novel therapeutics from stem cells.Moyra LawrenceAmanda EvansThomas MoreauMarta BagnatiMatthew SmartEnas HassanJahid HasanMonica PianellaJulie KerbyCedric GhevaertNature PortfolioarticleMedicineRENnpj Regenerative Medicine, Vol 6, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R Moyra Lawrence Amanda Evans Thomas Moreau Marta Bagnati Matthew Smart Enas Hassan Jahid Hasan Monica Pianella Julie Kerby Cedric Ghevaert Process analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMP
description	Abstract Quality, traceability and reproducibility are crucial factors in the reliable manufacture of cellular therapeutics, as part of the overall framework of Good Manufacturing Practice (GMP). As more and more cellular therapeutics progress towards the clinic and research protocols are adapted to comply with GMP standards, guidelines for safe and efficient adaptation have become increasingly relevant. In this paper, we describe the process analysis of megakaryocyte manufacture from induced pluripotent stem cells with a view to manufacturing in vitro platelets to European GMP for transfusion. This process analysis has allowed us an overview of the entire manufacturing process, enabling us to pinpoint the cause and severity of critical risks. Risk mitigations were then proposed for each risk, designed to be GMP compliant. These mitigations will be key in advancing this iPS-derived therapy towards the clinic and have broad applicability to other iPS-derived cellular therapeutics, many of which are currently advancing towards GMP-compliance. Taking these factors into account during protocol design could potentially save time and money, expediting the advent of safe, novel therapeutics from stem cells.
format	article
author	Moyra Lawrence Amanda Evans Thomas Moreau Marta Bagnati Matthew Smart Enas Hassan Jahid Hasan Monica Pianella Julie Kerby Cedric Ghevaert
author_facet	Moyra Lawrence Amanda Evans Thomas Moreau Marta Bagnati Matthew Smart Enas Hassan Jahid Hasan Monica Pianella Julie Kerby Cedric Ghevaert
author_sort	Moyra Lawrence
title	Process analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMP
title_short	Process analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMP
title_full	Process analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMP
title_fullStr	Process analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMP
title_full_unstemmed	Process analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMP
title_sort	process analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying european gmp
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/ec9c921fb0fa4a27a26eb34ffe692aee
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Process analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMP

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