FDA Approves First U.S. Cell-Based Manufacturing Facility For Flu Vaccine
By Cyndi Root
The Department of Health and Human Services (HHS) announced in a press release that the Food and Drug Administration (FDA) has approved the first manufacturing facility in the U.S. for seasonal influenza vaccine using cell-based technology. The HHS states that the new capability confirms the wisdom of a multi-use approach in emergency preparedness. Located in Holly Springs, NC and owned by Novartis of Basel, Switzerland, the facility is equipped and approved to manufacture cell-based vaccines against seasonal influenza and pandemic influenza viruses. Robin Robinson, Ph.D., Biomedical Advanced Research and Development Authority (BARDA), stated, “We support development of medical countermeasures – drugs, vaccines, diagnostics and devices – that can be used to diagnose or treat illness or injury in public health emergencies like pandemics or following acts of bioterrorism, as well as day-to-day medical conditions.”
Holly Springs Facility
BARDA and Novartis built the Holly Springs facility in 2009 in a partnership to increase domestic flu vaccine production. The facility is capable of traditional egg-based influenza vaccine production as well as novel cell culture-based manufacturing methods. If an influenza epidemic emerges, the facility is capable of producing 150 million adjuvanted doses of pandemic influenza vaccine within six months. The HHS awarded a contract to Novartis in June of 2012 for the manufacturing of medical countermeasures at Holly Springs, one of one of three Centers for Innovation in Advanced Development and Manufacturing in the U.S.
The Holly Springs site includes six buildings, primary and secondary production facilities, quality control testing, and office buildings. The facility sits on 185 acres and has approximately 475,000 gross square feet. Capital expenditures, excluding capitalized expenses, are about $650 million.
Cell-Based Influenza Virus
Novartis makes a cell-based influenza vaccine called Flucelvax, approved by the FDA in 2012. The vaccine is for active immunization for influenza subtypes A and B. With the FDA approval of the Holly Springs facility, Novartis is poised to manufacture 50 million doses of seasonal influenza vaccines.
BARDA Partnerships
BARDA leverages public-private partnerships to innovate and produce medical countermeasures. The agency focuses on diagnostics or treatments for bioterrorism and public health emergencies. The agency also helps new agents reach the market and it trains biopharmaceutical workers.