S65: Challenges Faced During the Flublok Approval Process

Protein Sciences Corporation uses the baculovirus expression vector system and insect cells to produce novel vaccines. This technology provides advantages of speed, cost, and safety and is generally considered a safe production system, with limited growth potential for adventitious agents that can infect humans.  Flublok^® influenza vaccine received FDA approval for the prevention of influenza in adults aged 18 – 49 on January 16, 2013, making this product the first licensed recombinant influenza vaccine.  In addition, we have pandemic influenza vaccines in clinical development. When used to produce an influenza vaccine, the composition of which changes annually, additional advantages of this expression system include:  rapid response to emerging strains, elimination of the need to handle live viruses (especially for pandemic influenza), and production of authentic antigen that does not require egg-adaptation.  This talk will share our quality and regulatory challenges experienced during the Flublok approval process.