‘Readiness’ as a model to explain the differing adoption rates of gene editing technology in the laboratory and industrial manufacturing sites

Advanced therapies utilise cells or tissues of genetic modification for therapeutic effect. ‘Institutional Readiness’ (IR) is a sociologically-informed model of technology adoption developed to assess the degree of ‘fit’ between advanced therapies and a clinical environment. In its current formulation, IR assesses ‘readiness’ of hospital sites to deliver finished (i.e. ready to use) advanced therapy products, using eight orthogonal categories. This paper extends the readiness framework to earlier stages of technology development. Using CRISPR/Cas9 gene editing as a case study, we adapt the dimensions of IR to assess the relative ease and speed of adoption of CRISPR/Cas9 in the research laboratory and the industrial manufacturing site. CRISPR gene editing is a useful case study because it is frequently associated with narratives of speed and acceleration, in terms of being ‘fast and easy’ to use in the laboratory and in the promissory aspiration that this will rapidly lead to novel medical products becoming available. Rapid adoption of CRISPR in the laboratory is attributed to close affinity with existing scientific techniques, skills and infrastructures, but in the industrial setting, readiness is lower and the speed of adoption falters as gene editing encounters the more complex, still-experimental ‘in-the-making’ environment of industrialisation and scale-up.