Introduction

The high cost of therapeutic protein production, whether for human or animal health, has limited the application and use of such cutting-edge therapeutics in developing countries. Alternative process technologies to traditional mammalian and bacterial expression systems have been explored by various groups and have led to clinical trials for several plant-expressed therapeutic proteins. The first plant-produced biological was marketed by Protalix and Pfizer for the treatment of Gaucher's disease and several global corporations are now involved in plant-based therapeutic protein production.

There are various advantages to the use of biopharming expression systems, including:

  • faster and easier production of large yields of therapeutic proteins;
  • relatively inexpensive production costs compared with current practices;
  • safer vaccine antigen production;
  • the production of more complex proteins than possible with micro-organisms; and
  • the potential production of proteins that cannot be produced in mammalian cell cultures.

Government support

The South African government has focused on biopharming as a means of developing the bioeconomy for more than a decade. Biopharming was one of the 'grand challenges' of the Department of Science and Technology's 10-Year Innovation Plan. Accordingly, a number of South African research institutions and small and medium-sized enterprises (SMEs) are actively involved in plant-based expression platforms for various therapeutic proteins, leveraging the advantages of these systems for the development of therapeutic proteins for the treatment of neglected diseases, emerging diseases and highly communicable diseases that traditional therapeutic biological systems have either ignored or been too slow or expensive to roll out to the market, particularly in the developing world.

Biopharming research programmes

The two largest research groups focusing on the production of human and animal vaccines and therapeutic proteins using plants are situated at the Council for Scientific and Industrial Research (CSIR) and the University of Cape Town (UCT). For example, the CSIR has produced RabiVir – a plant-made antibody cocktail for rabies prophylaxis – and plant-made subunit animal vaccines. The UCT has shown the first proof of efficacy of a plant-produced papillomavirus vaccine for humans and is also involved in various plant-made subunit animal vaccines. Further, AzarGen Biotechnologies is a South African SME involved in therapeutic protein production in plants, with their leading candidate recombinant product being a human surfactant protein that increases the survivability of premature infants. AzarGen has partnered with iBio, a US commercial bio-manufacturer for plant-expressed protein production. However, if the South African biopharming industry continues with the momentum that it currently has, local biopharming manufacturing facilities are also likely to be established.

Regulation and legislation

Biopharming regulation requires proper foundations in the form of biopharming rules and research and development policies. In South Africa, different government departments have already implemented legislation concerning plant-based protein production, including:

  • the Medicines and Related Substances Control Act (101/1965);
  • the Foodstuffs, Cosmetics and Disinfectants Act (54/1972);
  • the Genetically Modified Organisms Act (15/1997);
  • the National Environmental Management Act (107/1998); and
  • the National Environmental Management: Biodiversity Act (10/2004).

Comment

Given this infrastructure and the highly active local biopharming research community, South Africa is considered a promising jurisdiction for the production of plant-based therapeutic proteins, with many possible opportunities for investment and collaboration.

For further information on this topic please contact Joanne van Harmelen at ENSafrica by telephone (+27 21 410 2500) or email (jvanharmelen@ensafrica.com). The ENSafrica website can be accessed at www.ensafrica.com.

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