id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-252198-gs52k4lq	Onions, David	Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine	2010-09-30		.txt	text/plain	6592	290	41	We conclude that the theoretical risks arising from manufacturing seasonal influenza vaccine using MDCK-33016PF cells are reduced to levels that are effectively zero by the multiple, orthogonal processes used during production. In order to quantitatively assess potential risks represented by adventitious viruses, data were collected about growth properties of various relevant viruses in MDCK-33016PF cells, about the virus inactivating and virus clearance of the vaccine manufacturing process, and about the detection limits of applied PCR methods to detect adventitious viruses. Combining all data on the virus growth in MDCK-33016PF cells, on the inactivation or process removal of various model viruses, and with consideration of applicable detection limits for virus exclusion tests, a process-specific risk assessment was made using quantitative data relative to infectious doses. First a rigorous analysis of the MDCK-33016PF cells was undertaken to exclude the presence of infectious oncogenic viruses or infectious oncogenic viral genomes; secondly the manufacturing process was shown to be capable of inactivating potential virus contaminants at very high levels.	./cache/cord-252198-gs52k4lq.txt	./txt/cord-252198-gs52k4lq.txt