Kentucky BioProcessing (KBP) has signed an agreement with the South African-based Council for Scientific and Industrial Research (CSIR) to develop a commercially efficient process for RabiVir,TM—CSIR’s award-winning anti-rabies antibody developed in a start up venture with GreenPharmTM.
The announcement follows GreenPharm’s TM achievement in the Innovation Fund’s SA Bio Business Plan Competition* at the end of 2008. CSIR plant biotechnologists walked away with an investment indication of up to R15 million (approximately $2 million US) and an opportunity for further training in the USA.
The start-up venture holds tremendous potential for using plants (in particular tobacco) to generate proteins used in preventative post-exposure rabies treatment and other complex therapeutic proteins such as HIV antibodies at a competitive price. Before finalizing the partnership, representatives from CSIR toured KBP.
Contract research and development manager at CSIR Biosciences, Fanie Marais, says, “KBP is well respected for its expertise in producing clinical grade biotherapeutics in plants. It has world-class good manufacturing production compliant (cGMP) facilities and provides contract services for bench scale, pilot and manufacturing process development in this field. cGMP conditions are essential for the production of antibodies that will go into early phase of safety testing.
According to the agreement with the CSIR, KBP will assist in the development of a process for the purification and preparation of clinical grade monoclonal antibodies (i.e high purity antibodies suitable for use in clinical development). The technology will be transferred to the CSIR and as part of the technology transfer process, CSIR scientists will spend time at KBP for training in all stages of process development. The agreement with KBP will help us speed up the commercialization process of RabiVirTM.
“We will also obtain the necessary documentation from KBP as prescribed by the USA Food and Drug Administration to enable registration of the antibodies with the regulatory authorities,” Marias said. “This development bodes well not only for the successful production and commercialisation of clinical batches of an anti-rabies antibody, which would be packaged as a post-exposure prophylaxis, but also for human capital development within South Africa.”