Risk Management for Biological Products

Nieminen, Outi; Kurki, Pekka

doi:10.2165/00124363-200418030-00003

Cited by 6 publications

(2 citation statements)

References 33 publications

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“…6 Also controversial is the use of xenogeneic cells or materials for TE purposes. The main arguments mentioned are the risk of introducing pathogenic agents (bacteria, viruses, or other infectious agents) into humans, 24,[83][84][85][86][87][88][89][90][91][92][93][94] the serious immunological problems xenogeneic cells may cause if they are not genetically altered or physically isolated, 24,83,87,88,91 and the public acceptability of using animal cells=tissue. 87,88,91 Some people object to the introduction of animal cells=tissue into the human body as such; others reject the use of material from specific animal species on the basis of religious precepts (e.g., reservations of Muslims and Jews regarding the use of porcine cells=tissue).…”

Section: Papers Classified According To Phase In Developmentmentioning

confidence: 99%

Ethical Aspects of Tissue Engineering: A Review

Vries

Oerlemans

Trommelmans

et al. 2008

Tissue Engineering Part B: Reviews

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Section: Papers Classified According To Phase In Developmentmentioning

confidence: 99%

Ethical Aspects of Tissue Engineering: A Review

Vries

Oerlemans

Trommelmans

et al. 2008

Tissue Engineering Part B: Reviews

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“…Emerging TE technologies require very specialized services, which must be performed on schedule IJPPM 58,1 by skilled labor with significant impact on the total costs of the treatment. Production capabilities and supporting services must also be available for preventing and controlling biological hazards (Nieminen and Kurki, 2004;Heinonen et al, 2005) as well as ethical, legal and financial risks, which, however, will not be addressed further by the present paper. Stockholding services, transportation, medical counseling and services during follow-up, are examples of the many other services, which become an essential part of the product.…”

Section: Call For Research In Supply Chains For Advanced Medical Servmentioning

confidence: 99%

Services for distribution of tissue engineering products and therapies

Nordström¹,

Närhi²,

Vepsäläinen³

2008

Int J Productivity & Perf Mgmt

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If you would like to write for this, or any other Emerald publication, then please use our Emerald for Authors service information about how to choose which publication to write for and submission guidelines are available for all. Please visit www.emeraldinsight.com/authors for more information. About Emerald www.emeraldinsight.comEmerald is a global publisher linking research and practice to the benefit of society. The company manages a portfolio of more than 290 journals and over 2,350 books and book series volumes, as well as providing an extensive range of online products and additional customer resources and services.Emerald is both COUNTER 4 and TRANSFER compliant. The organization is a partner of the Committee on Publication Ethics (COPE) and also works with Portico and the LOCKSS initiative for digital archive preservation. AbstractPurpose -Tissue engineering (TE) offers treatments for chronic, life threatening, degenerative illnesses and possibilities for restoring cellular or organ functions that have been lost due to injuries or hereditary conditions. However, a prerequisite for the use of TE products as part of future therapies is the development of strategies for safe and efficient supply chain management and versatile services spanning from product development to a follow-up period of possibly decades. The present study aims to explore the future needs for services and extended supply chains for safe delivery of health care, procurement, distribution and long-term follow-up of TE products and therapies. Design/methodology/approach -Studies in operational disciplines and coordination systems for different types of supply chains and service networks are used to formulate a framework for developing services throughout product lifecycle. Case examples of TE products are presented to demonstrate complexity, microbial risks, services and long-term follow-up. The role of logistics and the necessary services are identified for products classified into experimental, therapy and standard products. Findings -The paper finds that, through the stages, the importance of logistics increases from an enabler to becoming a strategic tool, emphasizing logistics requirements in establishing a viable TE supply chain. New dimensions to existing service operations frameworks are needed where proactive tissue sourcing, long follow-up periods, short shelf life and biological risks call for enforcing flexible services with tissue banks, detailed tracing, authorization and regulation. Originality/value -The paper presents the discovery of the logistics services and service institutions that will become imperatives for the future success of TE products and therapies.

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Towards a Richer Debate on Tissue Engineering: A Consideration on the Basis of NEST-Ethics

et al. 2012

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In their 2007 paper, Swierstra and Rip identify characteristic tropes and patterns of moral argumentation in the debate about the ethics of new and emerging science and technologies (or "NEST-ethics"). Taking their NEST-ethics structure as a starting point, we considered the debate about tissue engineering (TE), and argue what aspects we think ought to be a part of a rich and high-quality debate of TE. The debate surrounding TE seems to be predominantly a debate among experts. When considering the NEST-ethics arguments that deal directly with technology, we can generally conclude that consequentialist arguments are by far the most prominently featured in discussions of TE. In addition, many papers discuss principles, rights and duties relevant to aspects of TE, both in a positive and in a critical sense. Justice arguments are only sporadically made, some "good life" arguments are used, others less so (such as the explicit articulation of perceived limits, or the technology as a technological fix for a social problem). Missing topics in the discussion, at least from the perspective of NEST-ethics, are second "level" arguments-those referring to techno-moral change connected to tissue engineering. Currently, the discussion about tissue engineering mostly focuses on its so-called "hard impacts"-quantifiable risks and benefits of the technology. Its "soft impacts"-effects that cannot easily be quantified, such as changes to experience, habits and perceptions, should receive more attention.

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Risk Management for Biological Products

Cited by 6 publications

References 33 publications

Ethical Aspects of Tissue Engineering: A Review

Ethical Aspects of Tissue Engineering: A Review

Services for distribution of tissue engineering products and therapies

Towards a Richer Debate on Tissue Engineering: A Consideration on the Basis of NEST-Ethics

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