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

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.

journal_name

Cytotherapy

journal_title

Cytotherapy

authors

Lipsitz YY,Milligan WD,Fitzpatrick I,Stalmeijer E,Farid SS,Tan KY,Smith D,Perry R,Carmen J,Chen A,Mooney C,Fink J

doi

10.1016/j.jcyt.2017.06.009

subject

Has Abstract

pub_date

2017-12-01 00:00:00

pages

1383-1391

issue

12

eissn

1465-3249

issn

1477-2566

pii

S1465-3249(17)30625-4

journal_volume

19

pub_type

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