A roadmap for cost-of-goods planning to guide economic production of cell therapy products
| Autor: | William D. Milligan, Kah Yong Tan, Charles Mooney, David Smith, Ian Fitzpatrick, Jessica Carmen, Robert Perry, Evelien Stalmeijer, John Fink, Allen Chen, Yonatan Y. Lipsitz, Suzanne S. Farid |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Cancer Research Immunology Cell- and Tissue-Based Therapy Tissue procurement 03 medical and health sciences 0302 clinical medicine Cog Market price Immunology and Allergy Production (economics) Humans Cost of goods health care economics and organizations Genetics (clinical) Transplantation Economic production Commerce Cell Biology Product (business) 030104 developmental biology Transformative learning Oncology Risk analysis (engineering) 030220 oncology & carcinogenesis Costs and Cost Analysis Business |
| Zdroj: | Cytotherapy. 19(12) |
| ISSN: | 1477-2566 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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