Engineered tissue products

The Biotechnology Sector of EMEA is Hkely to have primary responsibility for considering the authorization of engineered tissue products in the event they are classifiable as medicinal products [8]. 

While some potential therapeutic proteins can be isolated and purihed from natural sources, it may be impractical to extract a sufficient amount for therapeutic purposes. This is the case for tissue plasminogen activator (tPA). While its therapeutic potential was quickly recognized, the protein was present naturally in such small amount that it was not possible to obtain quantities sufficient for chnical evaluation. Advances in biotechnology, including the development of recombinant DNA engineering, permitted production of recombinant tPA in sufficient quantities to evaluate its effects on occluded coronary arteries and to eventually develop a product. 

F2450-04 ASTM Standard guide for assessing microstructure of polymeric scaffolds for use in tissue engineered medical products. 

Tissue engineering, describes products which are derived from cells and tissues. These may be autologous if derived from the patient s own cells and used to treat that patient or allogeneic if derived from the cells of one person to be used in the treatment of another. 

ASTM. F2103-01 Standard guide for characterization and testing of chitosan salts as starting materials intended Iot use in biomedical and tissue-engineered medical product applications (2001)... 

This awareness has been increasing for some time. Domish et al. announced in 2001 some of the work that was carried out by an ASTM committee on standardizing chitosan for tissue-engineered medical products that were reiterated at the 9th International Chitin Chitosan Conference (Domish et al. 2001, Domish and Kaplan 2003). It is likely that this missing link in the research-applications interaction will be closed in the not too distant future. 

No polymeric material is ideally elastic or immune to any change they all degrade irreversibly and at different rates. Tissues, on the other hand, have the ability to repair damage inflicted on them. There is therefore great interest in the development of engineered tissues as implants, both as pure biological products and as composites with fibers. 

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