US firms Sepragen and Neugenesis are teaming up to develop a high-throughput platform for monoclonal antibody and influenza vaccine production that is rapid, scalable and flexible enough to respond to a potential pandemic.
The project hopes to combine Sepragen's proprietary solid phase bioreactor system with Neugenesis' Neurospora-based expression technology and create a novel platform that is more efficient and less expensive than currently available production methods. Last November, the Influenza Vaccine Strategies for Broad Global Access report, which was compiled by the non-profit global health group PATH and the World Health Organization, identified an alarming shortfall in global vaccine production capacity.
The study suggested that, in the event of a pandemic, only 2.4 billion doses of the 13 billion needed worldwide could be synthesized in the six month production period required by current vaccine synthesis methods. The report concluded that, 'real-time' access, in which vaccine production is begun at the time of the outbreak based on the actual pandemic strain, is not a viable approach in the near-term.
Traditionally, influenza vaccines have been produced fertilized hen's eggs, in which the albumin serves as a rich growth medium. More recently, cell culture based methods have been developed to produce vaccines that do not have the allergenic potential of egg-derived products. Both methods are expensive and time consuming. In contrast, Neugenesis' system uses recombinant strains of the filamentous fungus Neurospora crassa that can be modified to express key influenza virus antigens such as the haemagglutinin and neuraminidase proteins. These proteins can then be harvested, processed and used to directly elicit an immune response.
Neugenesis' approach sidesteps the viral growth phase used in the synthesis of traditional vaccines, considerably expediting the process. Additionally, in combination with the high yields that can be produced using Sepragen's bioreactor, large scale implementation of the technique will allow for the rapid production of considerable quantities of antigenic proteins specific to the antigens of any pandemic strain that emerges. DARPA funding
In July last year, the US Defense Advanced Research Projects Agency (DARPA) awarded several firms, including the UK's deltaDOT, and US companies Xcellerex, Dowpharma, BioPharm Services and SRI International, contracts designed to accelerate the development of emergency protein and vaccine manufacturing technologies. Neugenesis, which also received a DARPA contract, said that it would use the available funds to support part of its collaboration with Sepragen. Company CEO Dorsey Stuart said that Sepragen's bioreactor technology would enable production of fast growing Neurospora and produce antibodies at high throughput.
He added that the firms' collaboration "may be able to increase production efficiency by an order of magnitude when compared with conventional systems and eventually enable a low cost vaccine for pandemic flu."
Sepragen chief Vinit Saxena was also upbeat about the deal. He commented that his firm "believe that our platform can provide the means for Neurospora to grow rapidly without the limitation of oxygen depletion."