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A roadmap for cost-of-goods planning to guide economic production of cell therapy products

Lipsitz, YY; Milligan, WD; Fitzpatrick, I; Stalmeijer, E; Farid, SS; Tan, KY; Smith, D; ... Fink, J; + view all (2017) A roadmap for cost-of-goods planning to guide economic production of cell therapy products. Cytotherapy , 19 (12) pp. 1383-1391. 10.1016/j.jcyt.2017.06.009. Green open access

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Abstract

Cell therapy products are frequently developed and produced without incorporating cost considerations into process development, contributing to prohibitively costly products. Herein we contextualize individual process development decisions within a broad framework for cost-efficient therapeutic manufacturing. This roadmap guides the analysis of cost of goods (COG) arising from tissue procurement, material acquisition, facility operation, production, and storage. We present the specific COG considerations related to each of these elements as identified through a 2013 International Society for Cellular Therapy COG survey, highlighting the differences between autologous and allogeneic products. Planning and accounting for COG at each step in the production process could reduce costs, allowing for more affordable market pricing to improve the long-term viability of the cell therapy product and facilitate broader patient access to novel and transformative cell therapies.

Type: Article
Title: A roadmap for cost-of-goods planning to guide economic production of cell therapy products
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.jcyt.2017.06.009
Publisher version: http://doi.org/10.1016/j.jcyt.2017.06.009
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: COG, allogeneic cell products, autologous cell products, cell therapy, cost of goods, facility costs, material costs, production costs, storage, tissue procurement
UCL classification: UCL
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering
URI: https://discovery.ucl.ac.uk/id/eprint/10027187
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