Plant-derived pharmaceuticals - the road forward

Abstract

Plant-derived pharmaceuticals are poised to become the next major commercial development in biotechnology. The advantages they offer in terms of production scale and economy, product safety, ease of storage and distribution cannot be matched by any current commercial system; they also provide the most promising opportunity to supply low-cost drugs and vaccines to the developing world. However, despite the promised benefits, the commercialization of plant-derived pharmaceutical products is overshadowed by the uncertain regulatory terrain, particularly with regard to the adaptation of good manufacturing practice regulations to field-grown plants. The success of such products also depends on careful negotiation of the intellectual property landscape, particularly the achievement of freedom-to-operate licenses for use in developing countries. This article considers the path ahead for plant-derived pharmaceutical proteins (PDPs) and the challenges that must be addressed if these products are to achieve the commercial success of their counterparts produced using more traditional systems. Developing countries that have taken the lead in this field are already building their own capacity in biotechnology, and might well be leaders in the adoption of plant biopharmaceutical manufacturing platforms, particularly given that they possess the advanced infrastructure and legislative capacity needed to develop or adopt these technologies. These countries include China, India, Brazil, Argentina and South Africa. South Africa has emerged as a keen adopter of GM technology, and has developed a national biotechnology strategy along with a substantial budget and a commitment to public investment in PDP initiatives.