Abstract

The science and policy of pharmaceuticals produced and/or delivered by plants has evolved over the past twenty-one years from a backyard remedy to regulated, purified products. After seemingly frozen at Phase I human clinical trials with six orally delivered plant-made vaccines not progressing past this stage over seven years, plant-made pharmaceuticals have made a breakthrough with several purified plant-based products advancing to Phase II trials and beyond. Though fraught with the usual difficulties of pharmaceutical development, pharmaceuticals made by plants have achieved pertinent milestones albeit slowly compared to other pharmaceutical production systems and are now at the cusp of reaching the consumer. Though the current economic climate begs for cautious investment as opposed to trail blazing, it is perhaps a good time to look to the future of plant-made pharmaceutical technology to assist in planning for future developments in order not to slow this technology’s momentum. To encourage continued progress, we highlight the advances made so far by this technology, particularly the change in paradigms, comparing developmental timelines, and summarizing the current status and future possibilities of plant-made pharmaceuticals.

Highlights

  • Vaccine development has advanced immensely over the last century

  • While conventional vaccines have reduced the burden of many life-threatening diseases, alternative methods for vaccine production have aimed to improve the number of diseases protected against, the quality and efficacy of the vaccines and their availability to a greater audience, especially to the less-privileged [1,2,3]

  • Each one has advantages and shortcomings with respect to recombinant protein production and a new vaccine candidate is often run through a battery of host production systems to determine the optimal one for expression

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Summary

Introduction

Vaccine development has advanced immensely over the last century. Several systems including E. coli, yeast, mammalian cells and insect cells, have been utilized for vaccine production. Each one has advantages and shortcomings with respect to recombinant protein production and a new vaccine candidate is often run through a battery of host production systems to determine the optimal one for expression. Close to 21 years ago, transgenic plants were proposed as an alternative production system for pharmaceutical protein, with cited advantages of decreased cost, increased ease of delivery and scale up, and decreased risk of contamination with animal and human pathogens. We review the evolution of whole plants and plant cells as pharmaceutical production systems, highlighting shifting paradigms, comparing the timeline of development to competing production systems, and summarizing the current status and future possibilities of plant-made pharmaceuticals

Development of the Plant-Made Vaccine Paradigm
Plant-Made Vaccines
The Successful Plant-Made Vaccine
Plant-Made Antibodies
Successful Plant-Made Antibodies
Additional Plant-Made Therapeutic Proteins
Successful Plant-Made Therapeutics
Comparing Development of Different Recombinant Production Systems
The Future of Plant Made Pharmaceuticals
12. BiolexTherapeutics
Findings
56. Therapeutic
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