2019
DOI: 10.1590/15174522-02105005
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Bio-objects: new conjugations of the living

Abstract: Rapid advances in the life sciences have led to a radical transformation in thinking about what life is: we now compose living beings as synthetic life, from the ground up. “Life” has been multiplied and fragmented in molecular and database form and can be embodied in anything from engineered organisms through organs grown outside the body to bioprinted materials. Such new forms of life disrupt social relationships, challenge boundaries between culturally defined categories, pose new questions for governance, … Show more

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Cited by 6 publications
(5 citation statements)
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“…As bioprinting is fairly new, and no commercialized product has been developed to date, no regulations currently affect bioprinting, as it is "in-between existing categories of living and non-living materials"; therefore, it is proposed as representing "bio-objects." 134 Nevertheless, it is likely that for clinical approval, the bioprinted cornea must possess data on preclinical and clinical studies conducted under good clinical practice, whereas production is performed under good manufacturing practices (GMP), similar to studies that have already been conducted with tissue-engineered corneas. 135,136 Currently, all of the research in terms of cornea bioprinting is still far from clinical testing.…”
Section: Outlooks and Future Perspectivesmentioning
confidence: 99%
See 1 more Smart Citation
“…As bioprinting is fairly new, and no commercialized product has been developed to date, no regulations currently affect bioprinting, as it is "in-between existing categories of living and non-living materials"; therefore, it is proposed as representing "bio-objects." 134 Nevertheless, it is likely that for clinical approval, the bioprinted cornea must possess data on preclinical and clinical studies conducted under good clinical practice, whereas production is performed under good manufacturing practices (GMP), similar to studies that have already been conducted with tissue-engineered corneas. 135,136 Currently, all of the research in terms of cornea bioprinting is still far from clinical testing.…”
Section: Outlooks and Future Perspectivesmentioning
confidence: 99%
“…As bioprinting is fairly new, and no commercialized product has been developed to date, no regulations currently affect bioprinting, as it is “in-between existing categories of living and non-living materials”; therefore, it is proposed as representing “bio-objects.” 134…”
Section: Outlooks and Future Perspectivesmentioning
confidence: 99%
“…In order to bring this to light, experts have developed a concept called “bio-objects,” which means that all kinds of biotechnologies fall “in-between” the existing categories of living and non-living matter. 83,84 These “bio-objects” do not fall into the standard regulatory frameworks which are based on the clinically well-established medicinal product categories. Consequently, these products require new regulations/laws for clinical trials and commercialization.…”
Section: Regulatory Roles and Responsibilities Of Approving Authoritiesmentioning
confidence: 99%
“…Complex aspects of tissue engineering and bioprinting make its therapeutic potential ethically complicated compared to biologics and drugs. 84,148 One of the major ethical concerns in TEMPs and bioprinted constructs is the cell source and its processing procedures. 149 Cells and engineered tissue-based therapies are considered as drugs or biologics in few countries like Japan and the EU union.…”
Section: Ethical Concerns On Temps 3d Printed and Bioprinted Tissuesmentioning
confidence: 99%
“…Anais_SHXIIIseu domínio ou, no caso do DIP [Departamento de Imprensa e Propaganda], próprios". (SIMIS: 2015, p. 32;50) A verdade é que o governo Vargas já vinha se valendo do cinema para outros fins: o Ministério da Agricultura, por exemplo, era um grande produtor de filmes institucionais com fins de propaganda internacional dos produtos brasileiros para exportação, assim como outros órgãos que produziam informativos, sendo que o DIP usará o cinema para seus próprios fins. (SIMIS:2015, p.110, 111) Mas, mesmo estando em diferentes departamentos, isso não significou que o estado varguista atendia às demandas dos agentes cinematográficos.…”
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