It was feared that, if the virus mutated to a form that can readily infect humans while retaining this high fatality, it could potentially cause a global pandemic of devastating proportions. The subsequent emergence of the less fatal, but related, influenza virus (H1N1) in 2009 only highlighted the lack of preparedness to respond effectively to any future influenza pandemic.

Central to the problem was a 50-year-old egg-based method of producing flu vaccines, a lengthy six to nine-month manufacturing process and the need to forecast and select the virus strains to be used in the vaccine at least six months ahead of the flu season – not to mention the annual demand for hundreds of millions of fertilized chicken eggs.

To overcome these problems, Synthetic Genomics in collaboration with Novartis employed synthetic biology, combining large-scale DNA sequencing, synthetic gene synthesis, and cell-based vaccine production, to rapidly deploy a new vaccine in response to a novel infection outbreak of avian influenza flu (H7N9) in 2013. During the first three days of human H7N9 cases, the H7N9 virus was sequenced, the H7N9 Haemagglutinin (HA) and Neuraminidase (NA) genes synthesized and cloned, and vaccine viral production initiated. Seven months later, Novartis announced positive clinical results, stating the vaccine was now in large-scale production for the rapid response demanded by any future pandemic.

Synthetic biology processes provide significant advantages for generating antigens and diagnostic reagents for disease detection, for accelerating the speed of vaccine production, and for improving overall vaccine performance and yield when using cell culture.