Manufacturing and production of advanced therapies: A case of blurred boundaries

Michael Morrison, Isabel Briz Hernandez and Conor M. W. Douglas

Chapter 12 in Handbook of Pharmaceutical Science and Technology Studies, 2026, pp 195-212 from Edward Elgar Publishing

Abstract: A shift is underway in the production of pharmaceuticals from a chemical basis towards one where the body's own biological processes have become the source of novel treatments. Here we draw on scholarship within Science and Technology Studies to describe challenges associated with that shift, and show that manufacturing (at an industry level) and production (understood more broadly as also including clinician-led interventions) of advanced therapies is associated with a blurring of longstanding boundaries in biomedicine. We point to how institutions and practices associated with advanced therapies are collapsing distinctions between sourcing materials, manufacturing, trialling, and regulation of these medicines. Furthermore, we demonstrate how regulations are being used to shape and make markets for advanced products, and how advanced therapies are challenging the distinction between standardized medicinal products and bespoke medical procedures. Finally, we show how the once-stringent border between product manufacturing and medical care is breaking down. Implications of this blurring include new roles for various actors in production, the prospects for – and associated challenges with – competing regulatory standards, as well as concerns for the bodies of patients caught in the intersection of research and care. We end with suggestions for promising lines for future research.

Keywords: Advanced therapy; Regulatory pharmaceuticalization; Mass customization; Blurring of boundaries; Access to medicines; Innovation pathways (search for similar items in EconPapers)
Date: 2026
ISBN: 9781035338443
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