id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-254890-4ynsgu6c	Heldens, J.G.M.	Veterinary vaccine development from an industrial perspective	2008-03-03		.txt	text/plain	9217	443	39	Live vaccine: Low passage lot for safety (GLP) on target species including pregnant animals in case indication is required High passage lot for efficacy: Onset of immunity and duration of immunity Inactivated vaccine: High passage lot for safety (GLP) and efficacy Licensing batches (10% commercial scale, GMP) -Consistency of production, process validation -Transfer of production process and control tests to manufacturing departments and quality control departments -Stability studies on antigen and final product in final container Field studies (GCP) -Safety -Efficacy derived from treated animals from which food is derived, and the consumer. The likely approach to develop vaccines would be, first, the cloning and site directed mutagenesis to turn the HA-gene into a non-pathogenic form, and, second, the production of so-called high growth re-assortants producing considerable amounts of the new HA protein, which is, among others, the protective antigen in influenza virus.	./cache/cord-254890-4ynsgu6c.txt	./txt/cord-254890-4ynsgu6c.txt