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

• This study looked at why CRISPR gene editing is taken up quickly in research labs but much more slowly in manufacturing treatments for patients. 
• The researchers used a framework called “readiness” to compare how well each setting can adopt new technologies. 
• They found that CRISPR spreads rapidly in labs because it is easy to use, affordable, and fits existing skills and equipment. 
• In contrast, turning CRISPR into therapies is slower because manufacturing requires strict regulation, specialised facilities, trained staff, and scalable production methods. 
• This shows that fast scientific progress does not automatically lead to fast patient treatments. 
• Improving how “ready” healthcare and manufacturing systems are could help bring gene editing therapies to patients more quickly.

This paper reports on qualitative interviews with academic and commercial scientists working with gene editing and gene therapy as treatments for human diseases in the UK. The interviews were carried out between 2018 and 2020. The paper draws on the field of Science and Technology Studies and uses the interview data to adapt an existing framework known as ‘Institutional Readiness’. Institutional Readiness is a set of six factors that can help assess if a hospital is ready to deliver cell and gene therapies. In this paper we adapt this framework to explain why research laboratories were well positioned to start using CRISPR gene editing very quickly but why moving CRISPR gene therapies into industrial manufacturing is much slower.

• This paper explores why a powerful gene editing tool, CRISPR, has been adopted very quickly in research laboratories but much more slowly when developing treatments for patients. It focuses on the journey from early scientific discovery to real-world medical use.
• The authors use a concept called “institutional readiness”, which looks at how prepared a setting (such as a lab, factory, or hospital) is to take on a new technology. Readiness includes factors like skills, equipment, organisation, costs, and regulation.
• In research laboratories, CRISPR was taken up rapidly because it fits well with what scientists already do. It is relatively cheap, easy to learn, and works with existing tools and expertise. Scientists can quickly try it out, share results with colleagues, and improve their methods. This created a strong sense that CRISPR is a useful and exciting tool, encouraging widespread adoption.
• However, developing CRISPR into a treatment is much more complex. Manufacturing gene editing therapies requires large-scale production, strict safety standards, and detailed regulation. Processes that work in a lab (often small-scale and hands-on) must be transformed into reliable, repeatable, and highly controlled systems suitable for patient use.
• This transformation is not straightforward. It involves new equipment, new skills, and new ways of working, as well as significant costs. Materials that are cheap and easily available for research can become expensive and slow to obtain when produced to clinical-grade standards. There are also challenges in training staff and building the necessary infrastructure.
• This is because gene editing is significantly different from things companies already know how to manufacture like small molecule drugs or vaccines
• The study highlights that industrial manufacturing is still “in the making” for gene editing therapies. 
• The process of experimentation and learning by trial and error does not stop when knowledge and technologies leave the laboratpry and move into industrialisation
• Many industrial processes are also still experimental, and there is uncertainty about how best to scale up production safely and efficiently.
• Unlike in the laboratory, learning by trial and error is costly and time consuming.
• The paper also challenges common narratives that new technologies like CRISPR will automatically lead to rapid medical breakthroughs. While research can move quickly, translation into therapies depends on wider systems, including industry, regulation, and healthcare delivery.
• Overall, the key message is that speed in science does not equal speed in patient access. The gap between discovery and treatment is shaped by how well different parts of the system are prepared to adopt and adapt to new technologies.
• The authors suggest that improving “readiness” across manufacturing and healthcare systems—such as investing in infrastructure, skills, and regulatory pathways—could help bring advanced therapies, including gene editing, to patients more effectively in the future.

• Abstract
• Introduction
• Case study: CRISPR/Cas9 gene editing for human biomedical application
• Readiness and technology adoption
  • Demand for new technology and strategic focus
  • Receptivity, adoptive capacity and enablers
  • Evaluation procedures and relative need and benefit of new technology
  • Sustainability
• Materials and methods
• Results
  • CRISPR in the laboratory
  • Industrialising gene editing
• Discussion
• Notes
  • Acknowledgements
  • Disclosure statement
  • Data availability statement
  • Notes on contributors
• References
• Supplementary data (separate document)

Open Access full text via:

https://www.tandfonline.com/doi/full/10.1080/13511610.2026.2637168