Cell and gene therapy manufacturing: the necessity for a cost-based development approach

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

“…Centralised manufacturing has been the dominant model for large-scale production of goods since the Industrial Revolution [1]. Centralising workers and materials to benefit from economies of scale was pioneered by the early 'Fordist' factories and allowed costs to be contained [2].…”

“…Despite the challenges in terms of batch reproducibility that decentralisation of manufacturing facilities may introduce [1], it remains an attractive choice in principle for manufacturing certain CGTs. This is primarily due to the perishability of these products and the limited options for storage and shipping making long-distance transit undesirable [6].…”

“…Thus, a relatively cost-efficacious labour force provides local assay expertise while the challenging assessments that require expensive capital expenditure and costlier labour are able to benefit from the centralisation cost-reduction methods. This practice of releasing 'at risk' [1] is an accepted practice in radiopharmaceuticals and oncology and this effort to partially decentralise would allow the local assay panel to build up enough confidence to release the product on the assumption that the full assay panel will be completed to validate the release criteria.…”