Decentralized manufacturing and institutional readiness: adoption as a distributed process

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JournalCell and Gene Therapy Insights
DatePublished - Jul 2019
Issue number10
Volume5
Number of pages8
Pages (from-to)1061–1067
Original languageEnglish

Abstract

The model of decentralized manufacture is said to offer a new approach
for more effective translation of cell and gene therapies to the clinic (and
indeed in other sectors). Much of this depends on ensuring that key processes such as scalability and traceability are well-understood and properly managed as products move through to the clinic. The adoption of
these therapies will require the creation of a novel trans-organizational
innovation space. The latter can be better understood through deploying
the social science model of institutional readiness to focus attention on
the specific capacities that are needed to create not merely working but
workable therapies, those that make sense in the clinical environment.
This article outlines the model of institutional readiness, comparing it
with the linear and primarily technically-based model of ‘technology
readiness levels’, showing how it can help anticipate the specific capacities needed to build a new (decentralized) innovation spac

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