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Please use this identifier to cite or link to this item: https://dspace.lboro.ac.uk/2134/21921

Title: Putting a price tag on novel autologous cellular therapies
Authors: Abou-El-Enein, Mohamed
Bauer, Gerhard
Medcalf, Nick
Volk, Hans-Dieter
Reinke, Petra
Keywords: Adoptive T-cell therapy
Commercialization
Cost of goods
Good manufacturing practice
Immunotherapy
Market adoption
Price
Regulation
Reimbursement
Scale-up
Issue Date: 2016
Publisher: © International Society for Cellular Therapy. Published by Elsevier Inc.
Citation: ABOU-EL-ENEIN, M. ... et al., 2016. Putting a price tag on novel autologous cellular therapies. Cytotherapy, 18 (8), pp. 1056–1061.
Abstract: Cell therapies, especially autologous therapies, pose significant challenges to researchers who wish to move from small, probably academic, methods of manufacture to full commercial scale. There is a dearth of reliable information about the costs of operation, and this makes it difficult to predict with confidence the investment needed to translate the innovations to the clinic, other than as small-scale, clinician-led prescriptions. Here, we provide an example of the results of a cost model that takes into account the fixed and variable costs of manufacture of one such therapy. We also highlight the different factors that influence the product final pricing strategy. Our findings illustrate the need for cooperative and collective action by the research community in pre-competitive research to generate the operational models that are much needed to increase confidence in process development for these advanced products.
Description: Closed access until 7 June 2017
Sponsor: This work was partially supported by a DFG-grant: SFB-TR36, project A2
Version: Accepted for publication
DOI: 10.1016/j.jcyt.2016.05.005
URI: https://dspace.lboro.ac.uk/2134/21921
Publisher Link: http://dx.doi.org/10.1016/j.jcyt.2016.05.005
ISSN: 1465-3249
Appears in Collections:Closed Access (Mechanical, Electrical and Manufacturing Engineering)

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