FDA Licenses First US Facility for Cell-Culture Influenza Vaccines - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Licenses First US Facility for Cell-Culture Influenza Vaccines


FDA has licensed the Novartis manufacturing facility in Holly Springs, N.C. for the commercial production of cell-culture influenza vaccines. The site, the first US facility of its kind, will produce seasonal and pre-pandemic influenza vaccines, and has the capacity to significantly ramp up production in the event of a pandemic, the company reports.

Novartis uses cell-culture technology to produce Flucelvax (influenza virus vaccine), the first FDA-approved seasonal influenza vaccine not manufactured with chicken eggs. Cell-culture technology offers several potential benefits over traditional influenza vaccine production in chicken eggs, Novartis reports. The manufacturing process can be controlled more easily and is more flexible, enabling the potential to scale up production quickly to develop large quantities of vaccines in the event of a pandemic.

Using the cell-culture technology, Novartis has developed a vaccine candidate for the H7N9 avian influenza virus, which was first reported in China in March 2013. This facility supplied a stockpile of H7N9 vaccine to the US government prior to the second wave of the outbreak in January 2014.

The Holly Springs facility is a result of a joint partnership between Novartis and the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA). The facility was the overall winner of the ISPE Facility of the Year Award in 2013.

Source: Novartis

 

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Click here