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Cited by 73Pharmaceutical Economics and PolicyCAR-T cell therapy researchBiomedical Ethics and Regulation

What does cell therapy manufacturing cost? A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings

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ten Ham, Renske M.T., Hövels, Anke M., Hoekman, Jarno, Frederix, Geert W.J., Leufkens, Hubert G.M., Klungel, Olaf H., Jedema, Inge, Veld, Sabrina A.J. +15 more·2020·Cytotherapy
DOI 10.1016/j.jcyt.2020.03.432
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Abstract

BACKGROUND AIMS: Recent technical and clinical advances with cell-based therapies (CBTs) hold great promise in the treatment of patients with rare diseases and those with high unmet medical need. Currently the majority of CBTs are developed and manufactured in specialized academic facilities. Due to small scale, unique characteristics and specific supply chain, CBT manufacturing is considered costly compared to more conventional medicinal products. As a result, biomedical researchers and clinicians are increasingly faced with cost considerations in CBT development. The objective of this research was to develop a costing framework and methodology for academic and other small-scale facilities that manufacture cell-based therapies. METHODS: We conducted an international multi-center costing study in four facilities in Europe using eight CBTs as case studies. This study includes costs from cell or tissue procurement to release of final product for clinical use. First, via interviews with research scientists, clinicians, biomedical scientists, pharmacists and technicians, we designed a high-level costing framework. Next, we developed a more detailed uniform methodology to allocate cost items. Costs were divided into steps (tissue procurement, manufacturing and fill-finish). The steps were each subdivided into cost categories (materials, equipment, personnel and facility), and each category was broken down into facility running (fixed) costs and operational (variable) costs. The methodology was tested via the case studies and validated in developer interviews. Costs are expressed in 2018 euros (€). RESULTS: The framework and methodology were applicable across facilities and proved sensitive to differences in product and facility characteristics. Case study cost estimates ranged between €23 033 and €190 799 Euros per batch, with batch yield varying between 1 and 88 doses. The cost estimations revealed hidden costs to developers and provided insights into cost drivers to help design manufacturing best practices. CONCLUSIONS: This framework and methodology provide step-by-step guidance to estimate manufacturing costs specifically for cell-based therapies manufactured in academic and other small-scale enterprises. The framework and methodology can be used to inform and plan cost-conscious strategies for CBTs.

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  • Centralized manufacturing remains the dominant approach for allogeneic therapies due to economies of scale and well-established GMP infrastructure.

    “Centralized manufacturing remains the dominant approach for such therapies due to its economies of scale and well-established GMP infrastructure (ten Ham et al., 2020).”

    From Isolator-based point-of-care manufacturing: a practical solution for GMP-compliant cell and extracellular vesicles therapy production (2025) · cites this paper as ten Ham et al., 2020

    The Discussion (page unavailable) says higher production volume may reduce facility costs and that sharing GMP facilities can spread costs and risks. It does not establish that centralized manufacturing is the dominant approach for allogeneic therapies, or that established GMP infrastructure explains such dominance. (LLM, conf=0.86)

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Authors
ten Ham, R. M. T., Hövels, A. M., Hoekman, J., Frederix, G. W. J., Leufkens, H. G. M., Klungel, O. H., Jedema, I., Veld, S. A. J., Nikolic, T., Van Pel, M., Zwaginga, J. J., Lin, F., de Goede, A. L., Schreibelt, G., Budde, S., de Vries, I. J. M., Wilkie, G. M., Dolstra, H., Ovelgönne, H., Meij, P., Mountford, J. C., Turner, M. L., & Hoefnagel, M. H. N.
Affiliations
  • Utrecht University (NL)
  • Leiden University Medical Center (NL)
  • Radboud University Nijmegen (NL)
  • Scottish National Blood Transfusion Service (GB)
  • Radboud University Medical Center (NL)
  • Medicines Evaluation Board (NL)
ORCID
Venue
Cytotherapy
Publisher
Elsevier BV
Published
2020-07
Volume
22
Issue
7
Pages
388-397
ISSN
1465-3249 (ISSN-L)
DOI
10.1016/j.jcyt.2020.03.432
OpenAlex
W3024228614
Cited by
73
References
2
Citations by year
2026: 14 · 2025: 14 · 2024: 13 · 2023: 9 · 2022: 11 · 2021: 11 · 2020: 1
FWCI
6.80
Type
journal article
Language
en
Open access
Licence
Locations
  • Cytotherapy (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Leiden Repository (Leiden University) (submittedVersion, cc-by)
  • Radboud Repository (Radboud University) (submittedVersion, other-oa)
  • Data Archiving and Networked Services (DANS) (submittedVersion, cc-by-nc-nd)
  • Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
  • Radboud Repository (Radboud University) (submittedVersion)
Topics
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
  • Health Sciences › Medicine › Oncology › CAR-T cell therapy research
  • Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
Keywords
cell therapy manufacturing, cost estimation, small-scale manufacturing, cost drivers, hidden costs, cell therapy
MeSH terms
Academies and Institutes, Commerce, Costs and Cost Analysis, Europe, Health Facilities, Humans, Cell- and Tissue-Based Therapy

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