1 research outputs found
Centralised versus decentralised manufacturing and the delivery of healthcare products: A United Kingdom exemplar
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 A study was undertaken building on previous, so far unpublished, semistructured
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