Protein Sciences Corporation recently announced that the U.S. Food and Drug Administration (FDA) licensed its Pearl River, NY manufacturing facility for the commercial manufacturing of Flublok influenza vaccine.
Flublok is the world’s first recombinant protein-based vaccine for the prevention of seasonal influenza disease, and is the only flu vaccine made in a 100% egg-free system using modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing.
Flublok is highly purified and does not contain any preservatives (e.g., thimerosal, a mercury derivative), egg proteins, gelatin or latex.
In addition, Flublok contains three times more antigen than traditional flu vaccines (3x45mcg hemagglutinin protein versus 3x15mcg hemagglutinin protein).
“The approval of our Pearl River facility accelerates the growth of Protein Sciences and Flublok,” said Manon Cox, President and CEO. “We will be able to manufacture Flublok at four times the scale compared to our Connecticut facility. This milestone enables us to substantially increase the availability of Flublok this year and in the future.”
This effort was backed by federal funding from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under Contract No. HHSO100200900106C.
