Comparability: Manufacturing, Characterisation and Controls Report of a UKRMP Pluripotent Stem Cell Platform Workshop

Published

July 10, 2016

Author(s)

Anne L. Plant

Abstract

This paper summarises the proceedings of a workshop held at Trinity Hall, Cambridge to discuss comparability and includes additional information and references to related information added subsequent to the workshop. Comparability is the need to demonstrate equivalence of product after a process change; a recent publication [1] states that this “may be difficult for cell-based medicinal products”. Therefore a well-managed change process is required which needs access to good science and regulatory advice and developers are encouraged to seek help early. The workshop shared current thinking and best practice and allowed the definition of key research questions. The intent of this report is to summarise the key issues and the consensus reached on each of these by the expert delegates.

Citation

Regenerative Medicine

Volume

11

Pub Type

Journals

Download Paper

DOI Link

Keywords

human pluripotent stem cell (PSC), biomanufacturing, cell therapies, quality attributes, regulatory

Citation

Plant, A. (2016), Comparability: Manufacturing, Characterisation and Controls Report of a UKRMP Pluripotent Stem Cell Platform Workshop, Regenerative Medicine, [online], https://doi.org/10.2217/rme-2016-0053 (Accessed October 9, 2025)