If successful, this new cell culture technology, licensed from Dutch biotech Crucell, will allow Sanofi Pasteur to reduce dependence on eggs while offering an additional reliable vaccine manufacturing technology.
The scale up and the clinical trial conducted are part of a contract awarded by the US Department of Health and Human Services (HHS) to accelerate the development of a new cell culture-based influenza vaccine.
According to the World Health Organisation (WHO), 5 to 15 per cent of the population is affected with upper respiratory tract infections in annual influenza epidemics.
Most influenza vaccines are currently produced using embryonated chicken eggs, so there is value to improving the timely production of new vaccines in large quantities to combat a potential future influenza pandemic.
Crucell's novel PER.C6 technology uses cell culture for the large-scale production of recombinant proteins and monoclonal antibodies, including influenza vaccine, where the virus is grown on specially selected cell lines instead of chicken eggs.
The strengths of the PER.C6 technology lie in its safety profile, scalability and productivity under serum-free culture conditions.
Crucell's PER.C6 cell line is derived from a single, human retina-derived cell, which was purposely immortalised using recombinant DNA technology.
As a result, PER.C6 cells can replicate indefinitely, allowing them to be cultured in single cell suspension under serum-free conditions in quantities appropriate for large-scale manufacturing.
Besides eliminating the need for chicken eggs, the cell culture process has the potential to reduce from four weeks to two or three weeks the start-up time for manufacturing once the virus strain has been identified, resulting in a more predictable manufacturing process.
This scale-up process for the flu vaccine was achieved under a subcontracting agreement between Sanofi Pasteur and Lonza Biologics.
Meanwhile, the clinical study Sanofi is conducting is the first step toward it filing a Biologics License Application (BLA) for a cell culture-based trivalent split inactivated seasonal influenza vaccine with the US Food and Drug Administration (FDA).
The phase I trial will be conducted on 100 healthy adults, 18-64 years of age, with half of them receiving the cell-based vaccine and the other half a traditional egg-based control vaccine.
Apart from influenza, Crucell's PER.C6 technology is being used in programmes for the development of vaccines against Ebola, malaria and West Nile disease.