According to the agreement, Delaware, US-based iBio will provide process development and manufacturing services at its Texas facility, and will assist CC-Pharming in preparing a site for eventual manufacturing in China.
The first project will focus on developing a plant-derived, ‘bio-better’ rituximab. Rituximab is marketed as ‘MabThera’ by Roche in Europe, and under ‘Rituxan’ by Biogen in the US. The reference product was first approved in 1997 for the treatment of certain B cell non-Hodgkin lymphomas.
“iBio and CC-Pharming are jointly pursuing the medical and business goal of introducing a plant-made antibody superior to rituximab in performance and more affordable than rituximab in price,” according to iBio.
Biopharma-Reporter (BPR) spoke with iBio’s CEO Robert Kay (RK) to discuss how its plant-based technology compares to traditional bioreactor systems, and why the biotech is looking to manufacture ‘green’ monoclonal antibodies in China.
BPR: How do you make ‘plant-derived’ antibodies?
RK: iBio uses plants as bioreactors in contrast to production of single-cell mammalian, bacterial or yeast culture systems to produce recombinant therapeutics. The plants function as ‘generic’ bioreactors. They can be grown constantly hydroponically at very large scale (> 300,000 kg/yr). Five week old plants are ‘transfected’ by a proprietary vector carrying the gene of interest. This transfection is a transient system that produces the desired protein in seven days post-transfection. The process does not require a transgenic plant. Plants cells have all of the eukaryotic cellular machinery for complex protein synthesis and post-translational modification.
iBio's technology provides a cost effective basis to use the ability of green plants to produce complex proteins ideally suited for human health applications. The iBio technology results in significant reductions in the time required to develop biotherapeutics, as well as significant reduction in the cost of bulk drug substance manufacturing.
BPR: How do plant-derived antibodies compare to traditional biologics?
RK: Unlike more conventional systems that fundamentally alter a host cell's DNA, with iBio technology, there is no need to clone, evaluate and scale-up high-producing animal cell clones. A gene of interest can be cloned and inserted into the iBio vectors and be ready for production at scale in months. The simplicity of the iBio technology comes from the use of whole plants for the manufacturing of protein, so the plants can be grown in compliance with pharmaceutical standards in a chemically defined medium, in climate-controlled interior spaces. The plants are grown in a chemically defined, inorganic salt solution and the automated systems ensure no human contact. There is no opportunity for adventitious virus contamination.
BPR: How could plant-derived antibodies benefit the industry?
RK: The key advantages of the iBio technology are speed, flexibility and lower cost. iBio’s technology provides rapid production of complex proteins like antibodies without the time and cost of selecting stable animal or human cells line or folding proteins after production in bacterial cells. The system allows clients to rapidly ‘downselect’ the best candidate for production and clinical trials.
This can save clients valuable time on the front end of product lead evaluation projects and even more during their progress toward pharmaceutical protein production for clinical trials and eventually commercial launch. iBio technology results in significant cost reductions in the production of antibody drugs, as well as significantly lower capital costs to build a manufacturing facility using our technology.
BPR: Why is iBio targeting the Chinese market? In response to industry growth in this region?
RK: China is a grossly underserved population in the area of biotherapeutics. China is the second largest pharmaceutical market in the world and is positioned for considerable growth, with regard to healthcare expenditure, in the coming years. China is moving rapidly to expand biologics production. iBio can provide a prepared, ‘turn key’ solution for Chinese partners. The iBio platform can lower the capital costs and time to market for biologics. iBio offers its collaborators a complete technology transfer package. This tech transfer includes building design and engineering, production of early stage clinical lots while a Chinese facility is being built, training in production and quality management in iBio’s large-scale facility in Texas, and a proven ability to make monoclonal antibodies, vaccines, and other biotherapeutics.
This ‘empowerment’ business model is a great opportunity for iBio and its collaborators. It is an optimal time to enter this market with an excellent partner, CC-Pharming – a company with deep expertise and a shared vision for bringing significant product benefits to the people of China.
