The production of vaccines and therapeutic antibodies in plants

Abstract

Biopharmaceuticals such as antibodies and recombinant subunit vaccines are generally produced on a commercial basis by process-scale fermentation in bacteria, yeast or animal cells. Plants and plant cells have joined the exclusive club of commercial production platforms comparatively recently, but they offer certain advantages over the more established systems particularly in terms of economy, scalability, response times and formulation options. After a promising start and then a rocky transition from early R&D to preclinical and clinical development, plants are now becoming more firmly established as an alternative to microbes and mammalian cells for the production of pharmaceutical proteins. Several plant-derived pharmaceuticals have undergone clinical trials and the first products for human use are approaching market authorization, with antibodies and vaccines strongly represented among these front runners. Although scientific advances have played an important role in the maturation of plant-based production technology, perhaps the most critical development has been the definition of a workable regulatory framework which has recently yielded the first processes for biopharmaceutical production in plants that comply with good manufacturing practice. In this chapter, we consider the state of the art in plant-based production systems for antibodies and vaccines and discus the development issues which remain to be addressed before plants become an acceptable mainstream production technology.