The NC Biotechnology Center in RTP is hosting this VaccinatioNCelebration to highlight the launch of this important flu vaccine, made by North Carolina biomanufacturing specialists employed by the Australian global pharmaceutical company Seqirus (suh-KEER-us).

The event is set for Tuesday.

Here is the backstory on the vaccine, the company, and the Holly Springs connection:

Flucelvax Quadrivalent: A Next-Generation Flu Vaccine

Flucelvax Quadrivalent is an influenza vaccine developed and produced by Seqirus.

The vaccine helps protect against four strains of influenza as recommended for the 2016-17 flu season by the World Health Organization (WHO) and the U.S. Food and Drug Administration: two influenza A viruses and two B viruses.

Flucelvax Quadrivalent is the successor to Flucelvax, a trivalent vaccine that protects against three strains of flu viruses: two strains of influenza A viruses and a single strain of influenza B virus.

Both versions of Flucelvax are produced with a novel process called cell culture, unlike the traditional process of growing vaccine components in poultry eggs.

Flucelvax was the first cell-culture flu vaccine approved for use in the United States, gaining approval from the FDA in 2012. Flucelvax Quadrivalent was approved in 2016.

Vaccine production using cell culture is the most significant advancement in flu vaccine manufacturing in the last 40 years.

With the cell-culture method, the vaccine viruses that protect against flu infection are grown, or cultured, in mammalian cells inside sterile, stainless-steel bioreactors.

Cell culture provides several benefits to individuals and to society at large.

Cell-cultured Flucelvax Quadrivalent:

  • Contains no antibiotics because it’s produced in a sterile environment.
  • Is free of preservatives and latex.
  • Has fewer added sterilizing agents.
  • Is faster to produce than with eggs.
  • Will allow quicker scale-up of production in the case of an influenza pandemic or bioterror attack.

Made by Seqirus in North Carolina

The evolution of Flucelvax has involved three successive corporate owners of the next-generation vaccine technology: Chiron, Novartis, and, now, Seqirus.

Seqirus was formed in July 2015 when the vaccines division of Novartis AG joined forces with bioCSL, the vaccine division of CSL Ltd. of Melbourne, Australia.

CSL, short for Commonwealth Serum Laboratories, is a notable vaccine pioneer:

This year it is celebrating the 100th anniversary of its founding in 1916.

Throughout its history, CSL has produced several human and veterinary vaccines that protected people and livestock from seasonal flu, flu pandemics and other infections.

CSL is a $45 billion global biotherapeutics company that employs more than 16,000 people and has operations in more than 30 countries.

Seqirus has now become the world’s second largest vaccine company with more than 2,000 employees worldwide and a commercial presence in 20 countries.

The Holly Springs plant

The North Carolina Biotechnology Center was actively involved in recruiting the Seqirus flu-vaccination plant to Holly Springs, N.C., when it was being planned by Novartis.

The plant is the first and only full-scale cell culture influenza vaccine manufacturing facility in the United States.

The plant was licensed by the FDA in 2014, and production of Flucelvax began that same year.

The facility, located on 185 acres, encompasses seven buildings connected by a central corridor. The manufacturing center alone encompasses 475,000 square feet (an area equal to about 10 American football fields).

About 550 full-time employees work at the plant.

The facility represents a capital investment of more than $1 billion.

Ready for a Flu Pandemic

Each year in the U.S., an average of 200,000 people are hospitalized with flu complications. Many more could be sickened or killed in a national or worldwide flu pandemic.

The Seqirus plant was made possible by a partnership with the U.S. Department of Health and Human Services to help protect the public from pandemic influenza threats.

With cutting-edge facilities, technologies and technical expertise, the Seqirus facility will be a reliable supplier of seasonal influenza vaccine with the ability to rapidly respond to pandemic threats.

The plant was designed to produce up to 200 million doses of influenza pandemic vaccine within six months of a declared pandemic.

Another N.C. connection

Another innovative company in the flu-vaccine industry, Medicago, also has a major presence in North Carolina.

Only 20 miles from Seqirus’ Holly Springs plant, Medicago uses plant-based technologies to develop and rapidly produce novel vaccines and antibodies at its $40 million facility in Research Triangle Park.

The 97,000-square-foot facility has the capacity to produce 30 million doses of quadrivalent seasonal influenza vaccine or 120 million doses of pandemic influenza vaccine.

The Defense Advanced Research Projects Agency, which funds breakthrough technologies for national security, invested $21 million in Medicago’s facility.