FDA Approval Pushes Novartis Into 21st Century Vaccine Development

By Trisha Gladd, Editor, Life Science Connect

In 2009, the world experienced a global threat in the form of H1N1. Despite a prompt response to the need for a vaccine in the United States, it was still not available until six months later and not enough doses were even produced to cover all Americans. During the year-long battle with the deadly virus, the CDC estimates between 8,870 and 18,300 people died due to H1N1-related complications. In the world of influenza vaccine production using chicken eggs, the response experienced during the H1N1 outbreak is not uncommon. Is this the best our industry can do?

At the 2013 ISPE Biotechnology Symposium, Scott Billman, director of engineering at Novartis Vaccines and Diagnostics, answered this question with a resounding NO. In his presentation, he detailed the plan between Novartis and the U.S. Department of Health and Human Services to defeat influenza and any threat of future pandemics by using groundbreaking cell culture technology to produce flu vaccines. This week, the FDA granted license to the state-of-the-art Novartis Flu Cell Culture manufacturing facility in Holly Springs, NC, where the first FDA-approved vaccine using cell culture technology, Flucelvax, is being produced.

Cell culture technology uses laboratory-grown mammalian cells that are capable of hosting a growing virus. The ability to freeze these cell lines and use them later to produce a flu vaccine in large quantities is just one feature of this technology that makes it so vital in the fight against pandemics. Because cell lines grow exponentially, there is an ability to thaw them out when needed and then scale up to the manufacturing levels needed in a matter of weeks.