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Regulatory and microbiological safety issues surrounding cell and tissue‐engineering products
Author(s) -
Galbraith Daniel N.
Publication year - 2004
Publication title -
biotechnology and applied biochemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.468
H-Index - 70
eISSN - 1470-8744
pISSN - 0885-4513
DOI - 10.1042/ba20030163
Subject(s) - tissue engineering , business , microbiology and biotechnology , chemistry , biochemical engineering , risk analysis (engineering) , computational biology , biology , engineering , genetics
Cell therapies and tissue‐engineered products that contain living cells are potentially some of the most exciting of the novel therapeutic products currently under development. These products, however, present a number of important safety issues, particularly with respect to the transmission of human viruses. In addition, the short shelf life of these products precludes the normally extensive characterization performed on other biotherapeutic products. Careful examination of the risks and extensive testing of the raw materials have been used in place of product testing to ensure safety.