Blood, sweat and tears : a case study of the development of cultured red blood cells for transfusion

This thesis is an in-depth case study of an interdisciplinary, paradigm breaking, research team who are seeking to develop cultured red blood cells (RBCs) for transfusion using stem cells (known as the BloodPharma project). It answers the research question: What can an in-depth case study of the BloodPharma project reveal about everyday scientific practice and the project management of a large research programme? The BloodPharma project occupies a unique position within the stem cell arena due to the size and multi-disciplinary nature of the project team, and the unique risk profile of cultured RBCs. The historical significance of blood donation is combined with the modern innovation of stem cell usage, to create a product which is both novel but also highly emotive. The case study comprises interviews with a range of stakeholders, laboratory observation, and participant observation of public outreach activities. In addition presence at team meetings and teleconferences has allowed an in-depth analysis of the project progression. The thesis has also drawn heavily on science and technology studies and scientific literature, as well as on information gathered from a wide variety of conferences and workshops. Key findings indicate that early stage laboratory work in this interdisciplinary project is achieved through the standardisation of work across different research spaces, with training and visual aids used to overcome the hurdle of tacit knowledge associated with the development of stem cell technologies. In designing early stage laboratory work the team looked to the human body as a benchmark of in vivo RBC production, using in vivo cells as a dual standard for which the team must aim, but cannot fall short of. Scale-up and standardisation were identified as the key challenges to the translation of this early stage laboratory work into a clinically useable product. These challenges require new expertise and innovation, and are an example of the translational obstacles of tacit knowledge and visual techniques which are found in the wider stem cell field. The use of target markets was identified by the team as a stepping stone to larger scale production, although in common with other stem cell therapies the clinical trials route to first-in-human use is still unclear. The uncertainty of regulation for stem cell products, and specifically how this relates to the BloodPharma project, is also a key finding of this thesis. Interactions with the regulatory system are seen as a necessity but also represent an area of confusion for laboratory researchers, requiring much specialist knowledge to understand and navigate regulatory documents. Regulatory expertise is brought to the BloodPharma project through reliance on particular members of staff. Public outreach has formed an important part of the BloodPharma project and shows the scientists stepping outside their primary area of expertise, a reflection of the broader trend amongst academic research to demonstrate ‘broader impact criteria’. Public outreach for the BloodPharma team was found to occupy a unique niche, given that the team must balance the promotion of a future product with the preservation of the current donation system. This research is of a case study which goes beyond the boundaries of the laboratory, to look not only at early stage laboratory work, but also at the way in which the team envisions future translation and regulatory hurdles, and the public outreach which must combine to develop a novel stem cell therapy. The thesis is the first in-depth case study to follow a large, interdisciplinary, stem cell team through the work they carry out both within the laboratory space, and outside it; challenging the idea of what it means to carry out scientific work in this novel area of stem cell therapies. DECLARATION OF OWN WORK This is to certify that the work contained within has been composed by me and is entirely my own work. No part of this thesis has been submitted for any other degree or professional qualification.