Decentralized manufacturing of cell and gene therapies: overcoming challenges and identifying opportunities
Open accessAbstract
Decentralized or "redistributed" manufacturing has the potential to revolutionize the manufacturing approach for cell and gene therapies (CGTs), moving away from the "Fordist" paradigm, delivering health care locally, customized to the end user and, by its very nature, overcoming many of the challenges associated with manufacturing and distribution of high volume goods. In departing from the traditional centralized model of manufacturing, decentralized manufacturing divides production across sites or geographic regions. This paradigm shift imposes significant structural and organisational changes on a business presenting both hidden challenges that must be addressed and opportunities to be embraced. By profoundly adapting business practices, significant advantages can be realized through a democratized value chain, creation of professional-level jobs without geographic restriction to the central hub and a flexibility in response to external pressures and demands. To realize these potential opportunities, however, advances in manufacturing technology and support systems are required, as well as significant changes in the way CGTs are regulated to facilitate multi-site manufacturing. Decentralized manufacturing is likely to be the manufacturing platform of choice for advanced health care therapies-in particular, those with a high degree of personalization. The future success of these promising products will be enhanced by adopting sound business strategies early in development. To realize the benefits that decentralized manufacturing of CGTs has to offer, it is important to examine both the risks and the substantial opportunities present. In this research, we examine both the challenges and the opportunities this shift in business strategy represents in an effort to maximize the success of adoption.
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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., 2017
In “Systems and technical security” (page unavailable), the paper calls for comparable quality-management systems and consistent standards across sites, and discusses integrated systems that communicate across sites to support oversight. In “Perspectives” (page unavailable), it describes collecting and logging network data. Our copy does not specify harmonized SOPs, digital batch records, remote QA, cloud-based audits, or centralized review of production and release data. (LLM, conf=0.86)
Experimental — accuracy not yet measuredPOC manufacturing is especially suited to autologous therapies by enabling onsite production, reducing transportation time, simplifying logistics, and shortening the vein-to-vein interval.
“Consequently, POC manufacturing is especially suited to these modalities by enabling onsite production within or near the clinical setting. This arrangement significantly reduces transportation time, simplifies logistics, and shortens the overall vein-to-vein interval (Harrison et al., 2017), which is critical for preserving cell viability and therapeutic potency.”
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., 2017
Applying CRISPR/Cas with non-viral delivery of template DNA to eliminate large genes or for orthotopic placement of transgenic constructs could reduce the potential of off-target effects.
“Applying CRISPR/Cas with non-viral delivery of template DNA to eliminate large genes (145) or for orthotopic placement of transgenic constructs (146) could also reduce the potential of off-target effects.”
From Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy (2021) · cites this paper as [146]
The Introduction defines cell and gene therapies, and the Management of challenging value chains section discusses transfection as a manufacturing step. Neither passage addresses CRISPR/Cas, non-viral template delivery, deletion of large genes, orthotopic placement, or off-target effects; searches for those terms found no relevant passage in our copy. (LLM, conf=0.75)
Experimental — accuracy not yet measured
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- Authors
- Harrison, R. P., Ruck, S., Medcalf, N., & Rafiq, Q. A.
- Affiliations
- University of Nottingham (GB)
- Loughborough University (GB)
- University College London (GB)
- Corresponding author
- Harrison, Richard P.
- Venue
- Cytotherapy
- Publisher
- Elsevier BV
- Published
- 2017-10
- Volume
- 19
- Issue
- 10
- Pages
- 1140-1151
- ISSN
- 1465-3249 (ISSN-L)
- OpenAlex
- W2742829995
- Cited by
- 72
- References
- 76
- Citations by year
- 2026: 13 · 2025: 11 · 2024: 11 · 2023: 3 · 2022: 4 · 2021: 9 · 2020: 5 · 2019: 10 · 2018: 3 · 2017: 3
- FWCI
- 2.01
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Cytotherapy (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Loughborough University Institutional Repository (Loughborough University) (submittedVersion, cc-by-nc-nd)
- UCL Discovery (University College London) (submittedVersion)
- Loughborough University Research Repository (Loughborough University) (submittedVersion, cc-by-nc-nd)
- Funders
- Engineering and Physical Sciences Research Council (EP/I017801/1)
- Engineering, Tissue Engineering and Regenerative Medicine (ETERM) Landscape fellowship grant
- EPSRC Fellowships in Manufacturing grant (EP/K037099/1)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Social Sciences › Business, Management and Accounting › Management Information Systems › Outsourcing and Supply Chain Management
- Health Sciences › Medicine › Oncology › CAR-T cell therapy research
- Keywords
- distributed manufacturing, cell and gene therapy, regulatory challenges, personalized medicine, manufacturing technology, business model transformation
- MeSH terms
- Workforce, Biotechnology, Humans, Organizational Innovation, Socioeconomic Factors, Genetic Therapy, Health Care Sector, Cell- and Tissue-Based Therapy
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