– Flublok is the world’s first FDA approved recombinant protein vaccine for the prevention of seasonal influenza
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 to gain U.S. FDA approval. Flublok is approved for individuals 18 and older.
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 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 production of vaccine is essential to deal with the pandemic effectively.”
Additionally, the Centers for Disease Control and Prevention (CDC) recently warned that flu vaccines may be ineffective this season because a new strain of H3N2 influenza virus is circulating that is not included in this year’s vaccines. The technology used to make Flublok offers a solution.
“A drift in influenza virus strain can effectively be addressed by a strong antibody response,” said Protein Sciences’ President and CEO Dr. Manon Cox. “Flublok contains 3x more antigen than traditional trivalent flu vaccines and induces a stronger antibody response against the influenza A viruses and a comparable response against influenza B viruses. The H3N2 virus is an influenza A virus and therefore we expect similar results to those observed in our 2007/08 clinical study where Flublok was effective against drifted H3N2 viruses.”
Unlike the other influenza vaccines that contain a part of the whole flu virus, Flublok comprises purified recombinant hemagglutinin antigens (HA), which correspond to the HAs expressed on the surface of influenza viruses, but are made without growing live flu viruses. 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 expresSF+® cells that express the HA protein 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 expresSF+ 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 of 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.
Influenza affects nearly 20 per cent of the global population every year, a number that can rise as high as 50 per cent during pandemic attacks. Furthermore, the majority of the high-risk population are those aged above 65 years, as well as immune-compromised individuals.
“Traditional flu vaccines are shown to be only 16 to 63 per cent effective against influenza,” remarked Chidambaram. “Flublok is formulated to contain three times the active ingredients in the regular shot, thereby making it a potentially superior immunogenic vaccine.”
In line with its recent product launch and commercialization efforts, Protein Sciences has made Flublok available at over 230 Passport Health locations across the US as of August 2014, in order to improve product availability and accessibility. Furthermore, Protein Sciences entered into a strategic alliance with Laboratorios Liomont, S.A. de C.V, a leading Mexican pharmaceutical company, during the same time of the year. Under the terms of the alliance, Protein Sciences has provided Liomont with an exclusive license to sell Flublok® (seasonal) and Panblok® (pandemic) influenza vaccines in Mexico and other potential Latin American Markets, in return for milestone payments and royalties on sales.
With a strong commitment to expand its horizon and technical know-how across therapeutic areas, Protein Sciences has further solidified its partnership with Diamyd Medical in September 2014, in order to develop a novel treatment for diabetes. Protein Sciences plans to manufacture products for upcoming late-stage clinical trials for type 1 diabetes involving Diamyd Medical’s recombinant glutamic acid decarboxylase (GAD) protein based on Protein Sciences’ proprietary BEVS technology. Additionally, in the wake of the Ebola outbreak in West Africa and beyond, Protein Sciences initiated development of an Ebola vaccine. A vaccine for Ebola is more readily made using recombinant technology, as traditional vaccine manufacturing would require growth of Ebola virus, which would be very dangerous.
This award is presented to the company that has excelled in developing an innovative product that leverages leading edge technologies and offers significant value added features/benefits. The product is also acknowledged for its potential for increased customer ROI and customer acquisition/penetration.
Frost & Sullivan Best Practices awards recognise companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.