- Flublok is the world's first FDA approved recombinant protein vaccine for the prevention of seasonal influenza

LONDON, 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 expresSF+^® 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 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 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.

"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."

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.

About Protein Sciences

Protein Sciences Corporation is a vaccine development and protein production company that is dedicated to saving lives and improving health through the creation of innovative vaccines and biopharmaceu­ticals. The Company's proprietary BEVS technology provides a fast, reliable and inexpensive platform for the production of high quality recombinant proteins, making it a powerful tool for producing vaccines and therapeutics when they are needed most. BEVS technology is covered by broad patents that include its proprietary expresSF+ cell line that is used to make all of the Company's products.  Learn more at www.proteinsciences.com.

About Flublok

Flublok influenza vaccine was approved on January 16, 2013 by the U.S. FDA for adults 18-49 years old.  Flublok is the world's first recombinant protein-based vaccine for the prevention of seasonal influenza disease and is the first to be made in a 100% egg-free system without growing influenza viruses.  Flublok is highly purified, has three times the amount of active ingredient in traditional influenza vaccines, and contains no egg proteins, preservatives (e.g., thimerosal, a mercury derivative), latex, antibiotics or adjuvants.

Safety Information

The most common side effect from Flublok is pain at the site of injection. Other side effects may occur and include fatigue, headache and muscle aches.  Flublok should not be administered to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component. Tell the doctor if you have ever experienced Guillain-Barre syndrome (severe muscle weakness) within 6 weeks of receipt of a previous dose of influenza vaccine. If you notice any other problems or symptoms following vaccination, please contact your healthcare professional immediately. Vaccination with Flublok may not protect all individuals.  Please see the complete Package Insert available at www.flublok.com for more information. 

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Contact:
Rachael Felberbaum
Protein Sciences Corporation
Manager, Scientific Communications
T: +1 203-599-6064 ext.164
E: rfelberbaum@ProteinSciences.com  

Kristina Menzefricke
Best Practices Group
Frost & Sullivan
T: +44 (0) 207 9157862
E: kristina.menzefricke@frost.com

SOURCE Frost & Sullivan