Regulatory and microbiological safety issues surrounding cell and tissue-engineering products.
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.
Galbraith
Daniel N
DN
BioReliance Corporation, Todd Campus, West of Scotland Science Park, Glasgow G20 0XA, Scotland, UK. dgalbraith@bioreliance.com
D064987:Cell- and Tissue-Based Therapy / Q000379:methods / Q000592:standards*; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence* / Q000592:standards; D018562:Disease Transmission, Infectious / Q000331:legislation & jurisprudence / Q000517:prevention & control*; D006801:Humans; D008828:Microbiological Techniques / Q000379:methods / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards*; D017768:Skin, Artificial / Q000592:standards / Q000821:virology; D023822:Tissue Engineering / Q000331:legislation & jurisprudence* / Q000379:methods / Q000592:standards; D014481:United States