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.

Plants as Factories for Human Pharmaceuticals: Applications and Challenges

“…Factors, such as plant phenolic compounds, plant pathogens, secondary metabolites, pesticides, and fertilizers, increase the difficulty of purifying a PMF product at an industrial level. Field crop-based PMF platforms, such as maize or rice, have pollen contamination issues which raise biosafety concerns as the pollen may contaminate non-transgenic crops that are part of normal agricultural production [ 44 , 45 , 46 ]. Currently, FDA has a restricted policy for using food crops for the production of recombinant pharmaceutical compounds [ 47 ].…”

A Plant-Produced Bacteriophage Tailspike Protein for the Control of Salmonella

“…Plant bioreactors have been growing in acceptance as feasible production platforms for therapeutic proteins, as they are highly scalable and can be established with little upfront cost ( Fischer et al, 2012 ). Protein drugs expressed in plant tissue are thought to be protected from digestive enzymes by the plant cell wall ( Kwon and Daniell, 2015 ), and are especially useful for veterinary applications where regulations allow administration of unpurified or partially purified extracts ( MacDonald et al, 2015 ). For example, leaf tissue can be harvested, lyophilized, and orally administered in capsules or suspended in a slurry removing costs associated with protein purification, administration, and cold-storage ( Kolotilin et al, 2014 ).…”

Platforms for Plant-Based Protein Production

“…However, since the scale of animal vaccination is so large, plant-based systems may represent the only cost-effective production platform on a scale for which other (non-plant-based production) methods are not competitive. Furthermore, plant-made veterinary vaccines, such as those made in seeds, fruits, and leaves, can be orally delivered as part of the animal feed, thus offering great convenience and economy in immunizing large populations of animals on farms [232]. In terms of commercialization potential, regulatory approval for the plant-made veterinary vaccines can be significantly less onerous than that for human vaccines [233].…”