id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-009376-a35a92gh	Lovatt, Archie	Applications of quantitative PCR in the biosafety and genetic stability assessment of biotechnology products	2002-01-07		.txt	text/plain	9214	523	48	Applications of Q-PCR within biotechnology are discussed with particular emphasis on the following areas of biosafety and genetic stability testing: (a) determination of the biodistribution of gene therapy vectors in animals; (b) quantification of the residual DNA in final product therapeutics; (c) detection of viral and bacterial nucleic acid in contaminated cell banks and final products; (d) quantification of the level of virus removal in process validation viral clearance studies; (e) specific detection of retroviral RT activity in vaccines with high sensitivity; and (f) transgene copy number determination for monitoring genetic stability during production. We are developing Q-PCR assays for these repeat regions for rodent and primate residual DNA to obtain sensitivity in the fg range, however, one advantage of using a gene such as ␤-actin is gene stability, as this target should not undergo copy number changes within a stable cell line.	./cache/cord-009376-a35a92gh.txt	./txt/cord-009376-a35a92gh.txt