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Cited by 40Pharmaceutical Economics and PolicyBiomedical Ethics and RegulationCAR-T cell therapy research

Centralised versus decentralised manufacturing and the delivery of healthcare products: a United Kingdom exemplar

Open access
Harrison, Richard P., Rafiq, Qasim A., Medcalf, Nicholas·2018·Cytotherapy
DOI 10.1016/j.jcyt.2018.05.003
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Abstract

BACKGROUND: The cell and gene therapy (CGT) field is at a critical juncture. Clinical successes have underpinned the requirement for developing manufacturing capacity suited to patient-specific therapies that can satisfy the eventual demand post-launch. Decentralised or 'redistributed' manufacturing divides manufacturing capacity across geographic regions, promising local, responsive manufacturing, customised to the end user, and is an attractive solution to overcome challenges facing the CGT manufacturing chain. METHODS: A study was undertaken building on previous, so far unpublished, semi-structured interviews with key opinion leaders in advanced therapy research, manufacturing and clinical practice. The qualitative findings were applied to construct a cost of goods model that permitted the cost impact of regional siting to be combined with variable and fixed costs of manufacture of a mesenchymal stromal cell product. RESULTS: Using the United Kingdom as an exemplar, cost disparities between regions were examined. Per patient dose costs of ~£1,800 per 75,000,000 cells were observed. Financial savings from situating the facility outside of London allow 25-41 additional staff or 24-35 extra manufacturing vessels to be employed. Decentralised quality control to mitigate site-to-site variation was examined. Partial decentralisation of quality control was observed to be financially possible and an attractive option for facilitating release 'at risk'. DISCUSSION: There are important challenges that obstruct the easy adoption of decentralised manufacturing that have the potential to undermine the market success of otherwise promising products. By using the United Kingdom as an exemplar, the modelled data provide a framework to inform similar regional policy considerations across other global territories.

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  • Establishing harmonized SOPs across sites, adopting digital batch records with centralized data monitoring, and enabling remote QA oversight could mitigate risks while ensuring consistent quality standards across multiple clinical settings.

    “Establishing harmonized SOPs across sites, adopting digital batch records with centralized data monitoring, and enabling remote QA oversight, such as cloud-based audits or centralized review of production and release data, could mitigate these risks while ensuring consistent quality standards across multiple clinical settings (Harrison et al., 2018; Harrison et al., 2017).”

    From Isolator-based point-of-care manufacturing: a practical solution for GMP-compliant cell and extracellular vesicles therapy production (2025) · cites this paper as Harrison et al., 2018

    The ‘Decentralisation of QC’ section proposes a central QC hub receiving material or data from local sites, and the ‘Conclusions and forward-looking statement’ identifies site-to-site comparability as a goal. The cited passages do not propose harmonized SOPs, digital batch records, centralized data monitoring, or remote QA audits, nor do they establish that these measures would ensure consistent quality. (LLM, conf=0.84)

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Cited by

Sorted by citations

Authors
Harrison, R. P., Rafiq, Q. A., & Medcalf, N.
Affiliations
  • University of Nottingham (GB)
  • University College London (GB)
  • Loughborough University (GB)
Corresponding author
Harrison, Richard P.
ORCID
Venue
Cytotherapy
Publisher
Elsevier BV
Published
2018-06
Volume
20
Issue
6
Pages
873-890
ISSN
1465-3249 (ISSN-L)
DOI
10.1016/j.jcyt.2018.05.003
OpenAlex
W2804526675
Cited by
40
References
2
Citations by year
2026: 8 · 2025: 4 · 2024: 5 · 2023: 6 · 2022: 3 · 2021: 8 · 2020: 1 · 2019: 5
FWCI
5.33
Type
journal article
Language
en
Open access
Licence
Locations
  • Cytotherapy (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Loughborough University Institutional Repository (Loughborough University) (submittedVersion, cc-by)
  • UCL Discovery (University College London) (submittedVersion)
  • Loughborough University Research Repository (Loughborough University) (submittedVersion, cc-by)
Funders
  • Engineering and Physical Sciences Research Council (EPSRC) Engineering Tissue Engineering and Regenerative Medicine (ETERM) Landscape Fellowship (EP/I017801/1)
  • EPSRC Fellowships in Manufacturing (EP/K037099/1)
Topics
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
  • Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
  • Health Sciences › Medicine › Oncology › CAR-T cell therapy research
Keywords
cell and gene therapy manufacturing, mesenchymal stem cells, patient-specific therapy, production capacity, United Kingdom
MeSH terms
Biological Products, Commerce, Costs and Cost Analysis, United Kingdom, Humans, Politics, Quality Control, Tissue Banks, Transportation, Urbanization, Genetic Therapy, Models, Organizational, Cell Engineering, Cell- and Tissue-Based Therapy

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