AzarGen Biotechnologies, South Africa’s only private plant-based biopharmaceutical company, is imagining a world-class commercial plant-made pharmaceutical facility for South Africa.

AzarGen, one of a few biopharming companies in the world focuses on developing human therapeutic proteins using advanced plant-based genetic engineering and synthetic biology techniques. Its leading product is a recombinant human surfactant protein, expected to increase the survivability of premature-born infants.

With no local commercial biomanufacturing facility, in 2016 the company entered into a commercial agreement with American based bio-manufacturer iBio Inc. to develop and manufacture the surfactant protein for the treatment of neonatal respiratory distress syndrome (RDS).

“Synthetic biology and genetic engineering research, development and manufacturing initiatives and programmes that focuses on the biopharmaceutical needs and affordability for South Africans are vital,” says Dr. Mauritz Venter, Chief Executive Officer at AzarGen. Imported medicine, especially biologicals, are very expensive.

“If South Africa is to secure its future medicine supply, the country should invest in building its own commercial bio-manufacturing facility to produce biological drugs that are not just generic copies of the originator biopharmaceutical. We need a commercial, world-class biomanufacturing facility utilising an expression technology that will enable the local production of biobetters at the highest standards at significantly lower cost,” adds Dr. Venter.

Key factors to support local drug discovery and biomanufacturing.

• A holistic approach to raise the awareness for affordable plant-based biological medicine.

A plant-made pharmaceutical platform is ideal for developing countries to establish a biopharmaceutical sector, not only for the production of biosimilars but for the production of novel biological drugs or modified derivatives of the originator product. The awareness of this ‘new industry’ potential can only be realised through collaborative efforts by government agencies, health systems, tertiary institutions, commercial networks and international partnerships. A biological drug with superior clinical efficacy at low cost can significantly improve the health status of citizens.

• Increase investment and industry development support to capture commercial opportunities

An accredited large-scale commercial local biopharma operations where biobetters can be manufactured will enable (1) the production of high-quality-low-cost biological drugs that are clinically superior and safer than the originator drug, (2) rapid response production of vaccines and (3) boost local industrial development. Africa’s pharmaceutical market has high growth potential. Research released in 2015 by consultants McKinsey and Company predicts that the market will be worth $40 to $65-billion by 2020.

• Unleash strong investment initiatives to support bioentrepreneurship and reduce unemployability of specialist science graduates.

The bio-economy strategy leans heavily towards boosting training and funding for students in life sciences but lacks a supporting framework that includes funding to stimulate entrepreneurial activities. This leads to high unemployability of life sciences graduates who face gloomy work prospects. Opportunities and spaces are needed where graduates can grow and hone their skills, and are supported to either pursue science entrepreneurship or find meaningful employment.

Advantages of a plant-based production platform versus mammalian and bacterial cells.

Plant-made manufactured biopharmaceuticals are not to be confused with medicinal plants or natural products.

“The plant applied is usually a tobacco variety, Nicotiana benthamiana, that is vacuum infiltrated with a modified Agrobacterium vector and the plant’s own protein-making machinery synthesizes the human therapeutic protein,” says Dr. Cobus Zwiegelaar, Chief Operating Officer at AzarGen. “The drug production process is safer, scalable and
potentially less costly - production, operating expenses and capital investments.”

The escalating cost of biological medicines not only poses growth risks for the national economy but puts South African healthcare at risk, especially biologicals to treat cancer and rare diseases.

“In plant manufactured pharmaceuticals safety is key as there is no animal or bacterial derived contamination. Plants enable the synthesis of complex biopharmaceutical proteins and production can easily scale to meet an increase in drug demand,” Dr. Zwiegelaar concludes.

• Over the last six years, AzarGen has successfully secured multiple rounds of investment which has allowed the venture to achieve significant milestones:

1. Obtaining a Freedom-to-Operate analysis conducted by one of the world’s leading biotechnology legal advisory firms;
2. Producing novel synthetic promoters with enhanced protein expression capabilities;
3. Expressing and purifying human surfactant protein on a ‘proof-of-concept’ scale;
4. Successfully lodging patent applications in several international territories;
5. Securing funding from the Industrial Development Corporation (IDC) in 2011 and 2015 (current funding earmarked for scale-up production at iBio CMO) and
6. Successful application of iBio’s proprietary technology to achieve the first milestone in its commercial development agreement with iBio, Inc (USA).

Public and private sector representatives are invited to connect and engage with AzarGen to further explore the benefits that commercial plant-based biomanufacturing holds for South Africa.