, April 30, 2013 /PRNewswire/ -- Based on its recent analysis of the influenza vaccines market, Frost & Sullivan recognises Protein Sciences with the 2013 Global New Product Innovation Award. Flublok is the world's first recombinant protein vaccine for the prevention of seasonal influenza disease in individuals aged 18–49 years to gain U.S. FDA approval.
Flublok is the first influenza vaccine in the world to be made in a 100 per cent egg-free medium without live influenza viruses. As a result, it can be produced quickly and without the risk of infections associated with the manufacture of traditional influenza vaccines grown in chicken eggs.
"Made from a novel insect cell line-based technology platform, which eliminates the use of chicken eggs and influenza virus, Flublok enables a faster start-up of the vaccine manufacturing process, as it does not depend on either egg supply or the availability of an infectious influenza virus," noted Frost & Sullivan Senior Research Analyst Aiswariya Chidambaram. "This speed is critical in the face of a pandemic outbreak of influenza when quick and safe production of vaccine is essential to deal with the pandemic effectively."
Flublok comprises purified recombinant hemagglutinin antigens (HA) that correspond to the HAs expressed on the surface of influenza viruses, but are made without growing infectious flu viruses, which is unlike the other influenza vaccines. The vaccine is tailored annually to provide protection against the latest strains of influenza by containing the corresponding recombinant HAs for those strains.
It is estimated that nearly 30 per cent of people do not take influenza vaccines owing to the misperception that they contract the disease from the vaccine. Since Flublok contains recombinant HA proteins, rather than HAs from the inactivated or live-attenuated influenza virus, it eliminates the perceived risk of contracting the flu from the vaccine.
Flublok is made using Protein Sciences' proprietary Baculovirus Expression Vector System (BEVS) platform technology, wherein baculovirus vectors are re-engineered using the genetic information that encodes HA protein and the
cells that express the HA protein are grown inside large stainless steel tanks.
"The BEVS technology platform is characterised by several advantages that include low cost, rapid protein production, proper folding of proteins, high cell densities, large volume scalability, and compliance with current good manufacturing practices (cGMP)," stated Chidambaram. "Additionally, the
SF+ cells have a rapid doubling time of 18–24 hours, easy scalability for cGMP manufacturing, and have been qualified for identity, stability and the lack retrovirus-like particles."
As a result, this time-tested proprietary technology platform and cell line has been widely adopted by several leading companies, such as Boehringer Ingelheim Vetmedica, Merck, Diamyd Medical and BioArctic Neurosciences among others, for the development of a broad range of vaccines and therapeutics.