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

Published version
Peer-reviewed

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Authors

Evans, Amanda 
Moreau, Thomas 

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.

Description

Keywords

StemCellInstitute

Journal Title

npj Regenerative Medicine

Conference Name

Journal ISSN

2057-3995
2057-3995

Volume Title

Publisher

Nature Research
Sponsorship
Medical Research Council (MR/R015724/1)
Defence Science and Technology Laboratory (Dstl) (14197)
MRC (via University College London (UCL)) (MR/S02090X/1)
Wellcome Trust (203151/Z/16/Z)
Medical Research Council (MC_PC_17230)