Bringing plant-based veterinary vaccines to market: Managing regulatory and commercial hurdles

作者：Jacqueline MacDonald, Ketan Doshi, Marike Dussault, J. Christopher Hall, Larry A. Holbrook, Ginny Jones, Angelo Kaldis, Cassidy L. Klima, Phil Macdonald, Tim A. McAllister, Michael D. McLean, Andrew Potter, Alex Richman, Heather M. Shearer, Oksana Yarosh, Han Sang Yoo, Edward Topp, Rima Menassa · 发表于：Biotechnology Advances · 年份：2015 · DOI：10.1016/j.biotechadv.2015.07.007 · 被引用次数：37 · 研究领域：Transgenic Plants and Applications、Viral gastroenteritis research and epidemiology、Animal Genetics and Reproduction

The production of recombinant vaccines in plants may help to reduce the burden of veterinary diseases, which cause major economic losses and in some cases can affect human health. While there is abundant research in this area, a knowledge gap exists between the ability to create and evaluate plant-based products in the laboratory, and the ability to take these products on a path to commercialization. The current report, arising from a workshop sponsored by an Organisation for Economic Co-operation and Development (OECD) Co-operative Research Programme, addresses this gap by providing guidance in planning for the commercialization of plant-made vaccines for animal use. It includes relevant information on developing business plans, assessing market opportunities, manufacturing scale-up, financing, protecting and using intellectual property, and regulatory approval with a focus on Canadian regulations.