Seqirus receives FDA approval for new manufacturing process

Seqirus announced FDA approval of its next generation cell-based manufacturing process at Holly Springs, North Carolina.  The approval will enable Seqirus to more than double current production levels of FLUCELVAX QUADRIVALENT for supply in the 2019/20 influenza season.

The approval came as Seqirus announced its FY18 earnings, which showed the company has delivered on its commitment to reach profitability just three years after it was created. The results represent more than $300 million turn-around, which has largely been driven by the successful scale up of the cell-based technology acquired from Novartis in 2015.

At the time Seqirus took over the cell-based influenza vaccine program, the Holly Springs facility produced around 3 million doses annually. Last year the company announced that it had boosted production to around 20 million doses of FLUCELVAX QUADRIVALENT per season by making technical improvements to the current process. This latest innovation will lead to the biggest step change in output yet, with more gains expected in the future.    

The Holly Springs facility was built in partnership with the US Biomedical Advanced Research and Development Authority (BARDA) to help combat influenza threats.

“Since acquiring this promising technology three years ago, we have been able to transition FLUCELVAX® from pilot scale to the most widely available cell-based influenza vaccine,” said Gordon Naylor, Seqirus president. “The approval of our next generation process will enable us to meet increasing demand for this innovative vaccine in the US market as well as support its launch in Europe next season.”

“Making the right vaccine available quickly can translate into more lives saved.  Increasing the speed and efficiency of producing influenza vaccines has game-changing implications for our nation’s health security. This type of progress clearly shows the difference that public-private partnerships can make,” said BARDA director, Dr. Rick Bright.