title: Bringing plant-based veterinary vaccines to market: Managing regulatory and commercial hurdles.
abstract: 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.
authors.affiliation: Agriculture and Agri-Food Canada, 1391 Sandford Street, London, Ontario N5V 4T3, Canada.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: MacDonald
authors.affiliation: Prairie Plant Systems Inc., 1 Plant Technology Road, Box 19A, RR#5, Saskatoon, Saskatchewan S7K 3J8, Canada.
authors.forename: Ketan
authors.initials: K
authors.lastname: Doshi
authors.affiliation: Zoetis Inc., 333 Portage Street, Kalamazoo, MI 49007, USA.
authors.forename: Marike
authors.initials: M
authors.lastname: Dussault
authors.affiliation: PlantForm Corp., 120 Research Lane, Suite 200, Guelph, Ontario N1G 0B4, Canada; School of Environmental Sciences, University of Guelph, Guelph, Ontario N1G 2 W1, Canada.
authors.forename: J Christopher
authors.initials: JC
authors.lastname: Hall
authors.affiliation: Prairie Plant Systems Inc., 1 Plant Technology Road, Box 19A, RR#5, Saskatoon, Saskatchewan S7K 3J8, Canada.
authors.forename: Larry
authors.initials: L
authors.lastname: Holbrook
authors.affiliation: Elanco Canada Ltd., 797 Victoria Road, Route 116, Victoria, Prince Edward Island C0A 2G0, Canada.
authors.forename: Ginny
authors.initials: G
authors.lastname: Jones
authors.affiliation: Agriculture and Agri-Food Canada, 1391 Sandford Street, London, Ontario N5V 4T3, Canada.
authors.forename: Angelo
authors.initials: A
authors.lastname: Kaldis
authors.affiliation: Agriculture and Agri-Food Canada, 5403 1st Avenue South, Lethbridge, Alberta T1J 4B1, Canada.
authors.forename: Cassidy L
authors.initials: CL
authors.lastname: Klima
authors.affiliation: Canadian Food Inspection Agency, 1400 Merivale Road, Ottawa, Ontario K1A 0Y9, Canada.
authors.forename: Phil
authors.initials: P
authors.lastname: Macdonald
authors.affiliation: Agriculture and Agri-Food Canada, 5403 1st Avenue South, Lethbridge, Alberta T1J 4B1, Canada.
authors.forename: Tim
authors.initials: T
authors.lastname: McAllister
authors.affiliation: PlantForm Corp., 120 Research Lane, Suite 200, Guelph, Ontario N1G 0B4, Canada.
authors.forename: Michael D
authors.initials: MD
authors.lastname: McLean
authors.affiliation: Vaccine and Infectious Disease Organization International Vaccine Centre (VIDO-InterVac), University of Saskatchewan, 120 Veterinary Road, Saskatoon, Saskatchewan S7N 5E3, Canada.
authors.forename: Andrew
authors.initials: A
authors.lastname: Potter
authors.affiliation: Agriculture and Agri-Food Canada, 174 Stone Road West, Guelph, Ontario N1G 4S9, Canada.
authors.forename: Alex
authors.initials: A
authors.lastname: Richman
authors.affiliation: Canadian Food Inspection Agency, 59 Camelot Drive, Ottawa, Ontario K1A 0Y9, Canada.
authors.forename: Heather
authors.initials: H
authors.lastname: Shearer
authors.affiliation: Canadian Food Inspection Agency, 59 Camelot Drive, Ottawa, Ontario K1A 0Y9, Canada.
authors.forename: Oksana
authors.initials: O
authors.lastname: Yarosh
authors.affiliation: College of Veterinary Medicine, Seoul National University, Seoul 151-742, Republic of Korea.
authors.forename: Han Sang
authors.initials: HS
authors.lastname: Yoo
authors.affiliation: Agriculture and Agri-Food Canada, 1391 Sandford Street, London, Ontario N5V 4T3, Canada.
authors.forename: Edward
authors.initials: E
authors.lastname: Topp
authors.affiliation: Agriculture and Agri-Food Canada, 1391 Sandford Street, London, Ontario N5V 4T3, Canada. Electronic address: Rima.Menassa@agr.gc.ca.
authors.forename: Rima
authors.initials: R
authors.lastname: Menassa
mesh_terms: D000820:Animal Diseases / Q000191:economics* / Q000276:immunology / Q000517:prevention & control*; D000818:Animals; D002170:Canada; D006801:Humans; D010944:Plants / Q000235:genetics / Q000378:metabolism; D014614:Vaccines, Synthetic / Q000191:economics* / Q000276:immunology
chemical_list: D014614:Vaccines, Synthetic
keywords: Antibody; Financing; Freedom to operate; Immunotherapeutic; Intellectual property; Molecular farming; Recombinant vaccine; Scale-up