The implicit in scientific discipline of Tissue technology has grown exponentially in recent old ages ; nevertheless, this has non been translated into a successful, commercial endeavor. This PG sheepskin thesis is an probe of the scientific discipline underpinning tissue technology and the factors impacting the commercial development.
During a meeting of the National Science Foundation in 1987, the term tissue technology was foremost introduced. Tissue technology can be considered a multidisciplinary engineering that uses donor cells to turn and spread out tissues in vitro. Tissue Engineering is the usage of a combination of cells, technology and stuffs, methods, and suited biochemical and physiochemical factors to better or replace biological maps. A normally used definition of tissue technology, as stated by Langer and Vacanti, is “ an interdisciplinary field that applies the rules of technology and life scientific disciplines toward the development of biological replacements that restore, maintain, or better tissue map or a whole organ ” ( Langer and Vacanti, 1993 ) . Tissue technology has besides been defined as “ understanding the rules of tissue growing, and using this to bring forth functional replacing tissue for clinical usage ” ( MacArthur and Oreffo, 2005 ) .
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Over the last decennary, tissue technology has emerged as a engineering, and this has now evolved into what is known as regenerative medical specialty, which non merely includes the replacing of tissues and variety meats, but besides fix and regeneration. Regenerative medical specialty provides huge promise for the intervention of hurts and disease and may convey radical alterations to the conventional methods of health care ( Mansbridge, 2006 ) .
The emerging tissue technology industry which grew up in the 1990s did convey some merchandises to the market. These were mostly skin replacements, with the one exclusion being Carticel, an autologous cell process used in handling gristle defects. Scientists are now technology cardiovascular tissues such as bosom valves ( Fabiani et al. , 1995 ) and blood vass ( Niklason et al. , 1999 ) ( Huynh et al. , 1999 ) . Encapsulated pancreatic islets have been implanted in the patients for the intervention of diabetes ( Lanza and Chick, 1997 ) and liver aid systems incorporating encapsulated hepatocytes have been clinically used to supply extracorporeal support to the patients with liver failure ( Chen et al. , 1997 ) . One of the first whole variety meats to hold been developed is the bioartificial vesica ( Oberpenning et al. , 1999 ) .
Present attacks to weave technology can be categorised into substitutive, histioconductive, and histioinductive ( Knight and Evans, 2004 ) . Substitutive attacks ( ex vivo ) are fundamentally whole organ replacing, whereas histioconductive attacks ( ex vivo ) require the replacing of losing or damaged parts of an organ tissue with ex-vivo concepts. In contrast, histioinductive attacks facilitate self-repair and may affect cistron therapy utilizing DNA bringing via plasmid vectors or growing factors.
In order to accomplish effectual, durable fix of damaged tissues a figure of standards must be fulfilled. 1 ) An equal figure of cells must be produced to make full the defect. 2 ) Cells must be able to distinguish into coveted phenotypes. 3 ) Cells must follow appropriate 3-dimensional structural support ( scaffold ) and produce ECM. 4 ) Produced cells must be structurally and automatically compliant with the native cell. 5 ) Cells must successfully be able to incorporate with native cells and get the better of the hazard of immunological rejection. 6 ) There should be minimum associated biological hazards ( Vats et al. , 2002 ) .
The beginning of cells utilized in tissue technology can be autologous ( from the patient ) , allogenic ( from a human giver but non immunologically indistinguishable ) , or xenogenic ( from a different species giver ) ( Naughton, 2002 ) . Autologous cells represent an first-class beginning for usage in tissue technology as they have small association with immune complications. Autologous cells are nevertheless non be effectual and batch controlled for cosmopolitan clinical usage. In contrast, allogenic cells offer advantages over autologous cells in footings of uniformity, standardisation of process, quality control and cost effectivity ( Knight and Evans, 2004 ) .
The bulk of tissue engineered merchandises are grown in the research lab by culturing and seeding cells from a patient or giver onto an appropriate scaffold. The cells are so stimulated to organize specific tissues that grow upon the scaffold and resemble the complex construction and biological map of natural tissues ( Leong et al. , 2003 ) . Scaffolds provide support for cells to proliferate and besides provide the construction which determines the form of the new tissue ( Hutmacher, 2000 ) . The tissue engineered merchandises generated utilizing conventional research lab methods are dearly-won due to the monetary value of bring forthing each unit being based on the cultivation, storage, transit and usage of life tissue. Another issue is the variable quality of each merchandise unit if produced manually in a research lab.
The companies doing tissue engineered merchandises encountered jobs which ranged from an deficient scientific discipline base, e.g. non understanding the mechanism of action, to overrating the patient demand, i.e. market size, to undervaluing the disruptiveness of this new engineering. It was hampered by holds in regulative blessing and in reimbursement blessing, and there were a assortment of less than optimum concern direction determinations ( Lysaght and Hazlehurst, 2004 ) . The cardinal factor was that the clip taken from the research lab to a marketable merchandise was far excessively long, with a consequence that several of these open uping companies, including both Advanced Tissue Sciences and Organogenesis, ran into terrible fiscal jobs.
In 2003 Organogenesis emerged from bankruptcy and since so has grown to over 300 employees, has treated over 200,000 patients, and enjoys Apligraf gross revenues of $ 60 million per twelvemonth with a uninterrupted addition in gross revenues. It is by far the largest endeavor selling a cell-based tissue technology merchandise. Organogenesis has accomplished this with really same merchandise that brought it to bankruptcy: Apligraf in 2007 is basically the same as Apligraf in 2002. This success is informed by the accomplishment of the new direction and in the focal point that the company has placed on the untechnical side of the concern: reimbursement, fabricating cost, and client satisfaction ( Lysaght et al. , 2008 ) .
Tissue technology potentially offers dramatic betterments in medical attention for 100s of 1000s of patients per annum, and every bit dramatic decreases in medical costs. Market estimations for tissue-engineered merchandises have been really promising, runing from $ 80 billion for the USA entirely to $ 400 billion worldwide ( Langer and Vacanti, 1993 ) . Tissue engineered replacing variety meats could hedge many of the jeopardies and jobs associated with donor variety meats, and at lower cost.
In transporting out this research, it is my purpose to analyze some of the implicit in factors that affect the development of the Tissue technology industry in the UK. Although there is a clear clinical demand for tissue engineered merchandises, companies have found it hard to go successful. This undertaking will besides assist me derive a better apprehension of the scientific base of tissue technology.
1.3 Aims & A ; Aims
The overall purpose of this PG sheepskin undertaking is to derive an apprehension of the scientific discipline underpinning tissue technology and the commercial restraints that are restricting its development.
The aims of the undertaking are:
- To supply an in deepness reappraisal of the scientific discipline underpinning tissue technology
- To place the political, economical, societal and technological factors that may impact the development of tissue technology
- To derive an apprehension of the barriers that are impacting the commercialization of tissue technology
1.4 Structure of thesis
• 2.0 Overview of tissue technology
Supplying an overview of the factors that are involved in tissue technology, and the work that has been carried out in this field.
• 3.0 Nature of tissue
Information sing the different types of tissues that are found in variety meats.
• 4.0 Cells and growing factors
Reflecting on the different types of cells that are used in tissue technology and supplying an penetration into function of growing factors and how they help in the formation of tissues and variety meats.
• 5.0 Scaffolds
Information on the different stuffs used for scaffolds and the processing techniques used to do scaffolds.
• 6.0 Bioreactors
An penetration into the different bioreactors that have been developed and the importance of them in the field of tissue technology.
• 7.0 Marketing analysis tools
Reflecting on the three market analysis tools which are Porters five forces, SWOT and PEST analysis.
• 8.0 Application of market analysis tool
Information gained from utilizing the PEST and SWOT tools on Tissue Regenix ltd.
• 9.0 Discussion
Discoursing the findings from the analysis conducted.