Putting a price tag on novel autologous cellular therapies.
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.
Berlin-Brandenburg Center for Regenerative Therapies, Charité University Medicine, Campus Virchow, Berlin, Germany; Department of Nephrology and Internal Intensive Care, Charité-University Medicine, Campus Virchow, Berlin, Germany. Electronic address: Mohamed.abou-el-enein@charite.de.
Mohamed
M
Abou-El-Enein
Institute for Regenerative Cures, University of California Davis, Sacramento, CA, USA.
Gerhard
G
Bauer
Wolfson School of Mechanical, Electrical and Manufacturing Engineering, Loughborough University, Loughborough, UK.
Nicholas
N
Medcalf
Berlin-Brandenburg Center for Regenerative Therapies, Charité University Medicine, Campus Virchow, Berlin, Germany; Institute of Medical Immunology, Charité University Medicine, Campus Virchow, Berlin, Germany.
Hans-Dieter
HD
Volk
Berlin-Brandenburg Center for Regenerative Therapies, Charité University Medicine, Campus Virchow, Berlin, Germany; Department of Nephrology and Internal Intensive Care, Charité-University Medicine, Campus Virchow, Berlin, Germany.
Petra
P
Reinke
D060846:Cell Engineering / Q000191:economics / Q000379:methods; D064987:Cell- and Tissue-Based Therapy / Q000191:economics*; D003132:Commerce; D006801:Humans; D016219:Immunotherapy, Adoptive / Q000191:economics / Q000379:methods; D013601:T-Lymphocytes / Q000637:transplantation; D035703:Therapies, Investigational / Q000191:economics*; D014182:Transplantation, Autologous / Q000191:economics
adoptive T-cell therapy; commercialization; cost of goods; good manufacturing practice; immunotherapy; market adoption; price; regulation; reimbursement; scale-up