FDA OKs Largest Biomanufacturing Facility in U.S.

By Lori Clapper

The US Food and Drug Administration (FDA) gave its blessing to the Novartis manufacturing facility in Holly Springs, N.C., licensing it for the production of cell-culture influenza vaccines. Now that the Holly Springs facility is licensed, the vaccine will be produced in the U.S. for the first time.

"This is the first U.S. facility of its kind and is now approved for commercial production. The site will produce seasonal and pre-pandemic influenza vaccines, and has the capacity to significantly ramp up production in the event of a pandemic," according to a company release.

The 430 thousand square-foot facility employs 500 people and is considered the largest biomanufacturing plant in the U.S. Much of the staff was trained through North Carolina State University’s Biomanufacturing Training and Education Center (BTEC), the statewide BioNetwork community college program and other specialty training programs in North Carolina.

In addition, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority helped Novartis fund the project, to the tune of $289 million, NC Biotech reported.

Cell culture is not new to Novartis. The company utilized this technology to produce the first FDA-approved seasonal flu vaccine, Flucelvax, which is not manufactured via the traditional method using chicken eggs.

Most recently, Novartis utilized cell culture technology to rapidly develop a vaccine candidate for the H7N9 avian influenza virus, first reported in China in March 2013. In response, the company also supplied a stockpile of H7N9 vaccine to the U.S. government prior to the second wave of the outbreak in January 2014.

Cell culture technology provides the following benefits as compared to traditional flu vaccine manufacturing:

• The manufacturing process is more easily controlled and is much more flexible.
• Production scale-up is quick, and large quantities of vaccines can be produced in case of a pandemic.

"Cell-culture technology is the first major advancement in influenza vaccine production in the US in more than 40 years. We are proud to be at the forefront of this innovation, which will allow us to deliver on our public health and health security commitments," said Andrin Oswald, Division Head, Novartis Vaccines. "With this award-winning, state-of-the-art facility, we will be able to not only offer U.S. consumers an antibiotic- and preservative-free alternative for the yearly seasonal flu vaccination, but also be better prepared for future pandemic threats."