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

作者：Lipsitz Yonatan Y^*; Milligan William D; Fitzpatrick Ian; Stalmeijer Evelien; Farid Suzanne S; Tan Kah Yong; Smith David; Perry Robert; Carmen Jessica; Chen Allen; Mooney Charles; Fink John

来源：Cytotherapy, 2017, 19(12): 1383-1391.

DOI：10.1016/j.jcyt.2017.06.009

• cell therapy
• cost of goods
• COG
• autologous cell products
• allogeneic cell products
• tissue procurement
• material costs
• facility costs
• production costs
• storage

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.

• 出版日期2017-12