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
Cytotherapyjournal_title
Cytotherapyauthors
Lipsitz YY,Milligan WD,Fitzpatrick I,Stalmeijer E,Farid SS,Tan KY,Smith D,Perry R,Carmen J,Chen A,Mooney C,Fink Jdoi
10.1016/j.jcyt.2017.06.009subject
Has Abstractpub_date
2017-12-01 00:00:00pages
1383-1391issue
12eissn
1465-3249issn
1477-2566pii
S1465-3249(17)30625-4journal_volume
19pub_type
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