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Between Craft and Standardized Production

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Craft in Biomedical Research

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Abstract

This chapter discusses current tensions and unfolding complexities between translational and basic research and the implications to the craft of biomedical research by turning to stem cell researchers’ accounts and experiences on the “ethos” of translation. It also traces the effort to accelerate the clinical use of stem cells to two high-profile international projects building large-scale iPS cell line repositories, the StemBANCC project and the EBiSC (European Bank for Induced Pluripotent Stem Cells) project. It shows that biobanks engender changes in relationships between biomedical scientists, their research material, and patients as donors of original tissue. It is argued that these changes are consequential to the material politics of stem cell research.

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Notes

  1. 1.

    For ethnographic and historical analyses on how scientists in biology and genomics become involved in collaboration with the industry, and the ensuing challenges of making the worlds of science and industry meet, see, for example , Kleinman (2003), Rabinow (1996, 1999), Shapin (2008), and Sunder Rajan (2007). Steven Shapin (2008, p. 229) observes that late modern “entrepreneurial science” is often represented either as all virtue, helping the economy, curing disease, and making science more relevant, or all vice, corrupting the university, distorting the integrity of science, and setting profits over human well-being. Industrialized and entrepreneurial science “never escapes the vocabularies of moral value”. I recognize this analytical challenge and try to tackle it through the perspective of scientific craftwork that, as I show in this chapter and the following ones, weaves together the threads of basic and translational research in complex ways.

  2. 2.

    Arguably, high-quality cell lines in large enough quantities are not the only issue in getting human pluripotent stem cells into clinical use and to the pharmaceutical market . An identified concrete bottleneck for translational medicine is that while the development of new cell-based products remains highly experimental and largely led by academic investigators, research groups without existing Good Manufacturing Practice (GMP) compliant facilities are often unable to meet the costs needed for nonclinical and clinical studies (Belardelli et al. 2011; Maciulaitis et al. 2012; Pearce et al. 2014). The lack of required production space with buildings, cleanrooms, and trained staff adequate for GMP is the major problem. According to academic stakeholders, GMP environments have to be invested for, in additions to human resources required for the “burden of paperwork” associated with GMP (Pearce et al. 2014). Previous studies on the ATMP Regulation show that research units in hospitals and public tissue establishments, or biobanks , seem to be discouraged by the industrial-scale GMP and marketing authorization requirements (Mansnérus 2015). The ATMP Regulation includes the aspiration that public biobanks would be able and willing to provide high-quality cells and tissues for those needing the material but would also take themselves part in the product development, as competitors to commercial tissue engineering companies. Currently it appears however that the role of public tissue establishments is limited to the role of a materials supplier, because they have not been able to meet the GMP-compliance costs and marketing authorization requirements (Mansnérus 2015).

  3. 3.

    The term “Finnish Disease Heritage” refers to an organizing principle first published in 1972 in a Finnish medical publication and in the following year in English, referring to the existence of certain rare diseases in Finland. The principle of national genetic specificity has been a widely shared, powerful imaginary for Finnish biomedical scientists, as Aaro Tupasela (2016) has shown, whereby the population and its unique genetic characteristics have become an important part of nation-building, also in the form of national innovation policy. The extensive patient medical records the Finnish welfare state health care system has kept are understood as another means to strive for national biomedical excellency (Tarkkala forthcoming).

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  1. University of Tampere, Tampere, Finland

    Mianna Meskus

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  1. Mianna Meskus
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Meskus, M. (2018). Between Craft and Standardized Production. In: Craft in Biomedical Research. Palgrave Macmillan, New York. https://doi.org/10.1057/978-1-137-46910-6_3

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  • DOI: https://doi.org/10.1057/978-1-137-46910-6_3

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  • Publisher Name: Palgrave Macmillan, New York

  • Print ISBN: 978-1-137-47552-7

  • Online ISBN: 978-1-137-46910-6

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