What does cell therapy manufacturing cost? A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings
Cytotherapy, vol. 22, pp. 388–397
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.
Authors 23
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Renske M.T. ten Ham corresponding
Utrecht University · Medicines Evaluation Board
Affiliation as printed
Division of Pharmacoepidemiology and Clinical Pharmacology of the Utrecht Institute for Pharmaceutical Sciences (UIPS); Dutch Medicines Evaluation Board, Utrecht, The Netherlands. Electronic address: R.M.T.tenHam@uu.nl
Division of Pharmacoepidemiology and Clinical Pharmacology of the Utrecht Institute for Pharmaceutical Sciences (UIPS)
Dutch Medicines Evaluation Board, Utrecht, The Netherlands
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Affiliation as printed
Division of Pharmacoepidemiology and Clinical Pharmacology of the Utrecht Institute for Pharmaceutical Sciences (UIPS)
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Affiliation as printed
Division of Pharmacoepidemiology and Clinical Pharmacology of the Utrecht Institute for Pharmaceutical Sciences (UIPS); Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University
Division of Pharmacoepidemiology and Clinical Pharmacology of the Utrecht Institute for Pharmaceutical Sciences (UIPS)
Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University
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Utrecht University · University Medical Center Utrecht
Affiliation as printed
Division of Pharmacoepidemiology and Clinical Pharmacology of the Utrecht Institute for Pharmaceutical Sciences (UIPS); Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University
Division of Pharmacoepidemiology and Clinical Pharmacology of the Utrecht Institute for Pharmaceutical Sciences (UIPS)
Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University
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Affiliation as printed
Division of Pharmacoepidemiology and Clinical Pharmacology of the Utrecht Institute for Pharmaceutical Sciences (UIPS); Lygature, Utrecht
Division of Pharmacoepidemiology and Clinical Pharmacology of the Utrecht Institute for Pharmaceutical Sciences (UIPS)
Lygature, Utrecht
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Affiliation as printed
Division of Pharmacoepidemiology and Clinical Pharmacology of the Utrecht Institute for Pharmaceutical Sciences (UIPS)
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Leiden University Medical Center
Affiliation as printed
Department of Hematology, Leiden University Medical Center, Leiden, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Hematology, Leiden University Medical Center, Leiden, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Immunohematology and Blood transfusion, Leiden University Medical Center, Leiden, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Immunohematology and Blood transfusion, Leiden University Medical Center, Leiden, The Netherlands
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Jaap Jan Zwaginga Aachen Department of Immunohematology and Blood Transfusion Sanquin Research Center for Clinical Transfusion Research and Jon J van Rood Center for Clinical Transfusion Science
Leiden University Medical Center · Sanquin · Jon J van Rood Centre for Clinical Transfusion Research
Affiliation as printed
Department of Immunohematology and Blood transfusion, Leiden University Medical Center, Leiden, The Netherlands; Sanquin Research, Center for Clinical Transfusion Research and Jon J van Rood Center for Clinical Transfusion Science, Leiden University Medical Center, Leiden, Netherlands
Department of Immunohematology and Blood transfusion, Leiden University Medical Center, Leiden, The Netherlands
Sanquin Research, Center for Clinical Transfusion Research and Jon J van Rood Center for Clinical Transfusion Science, Leiden University Medical Center, Leiden, Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands
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Radboud University Medical Center
Affiliation as printed
Department of Pharmacy, Radboud university medical center, Nijmegen, The Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Molecular Life Sciences
Affiliation as printed
Department of Tumor Immunology, Radboud university medical center, Radboud Institute for Molecular Life Sciences, Nijmegen, The Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Molecular Life Sciences
Affiliation as printed
Department of Tumor Immunology, Radboud university medical center, Radboud Institute for Molecular Life Sciences, Nijmegen, The Netherlands
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Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Molecular Life Sciences
Affiliation as printed
Department of Tumor Immunology, Radboud university medical center, Radboud Institute for Molecular Life Sciences, Nijmegen, The Netherlands
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Scottish National Blood Transfusion Service
Affiliation as printed
Advanced Therapeutics, Scottish National Blood Transfusion Service, Edinburgh, United Kingdom
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Radboud University Medical Center · Radboud Institute for Molecular Life Sciences
Affiliation as printed
Laboratory of Haematology, Department of Laboratory Medicine, Radboud university medical center, Radboud Institute for Molecular Life Sciences, Nijmegen, The Netherlands
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Affiliation as printed
Dutch Medicines Evaluation Board, Utrecht, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands
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Scottish National Blood Transfusion Service
Affiliation as printed
Advanced Therapeutics, Scottish National Blood Transfusion Service, Edinburgh, United Kingdom
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Scottish National Blood Transfusion Service
Affiliation as printed
Advanced Therapeutics, Scottish National Blood Transfusion Service, Edinburgh, United Kingdom
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Affiliation as printed
Dutch Medicines Evaluation Board, Utrecht, The Netherlands
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