Vaccine manufacturing facility expansion
In November 2018, Australia-based biotherapeutics company Seqirus announced plans to expand its flu vaccine manufacturing facility in Holly Springs, North Carolina.
The $140m expansion will allow Seqirus to meet the growing requirements of its cell-based quadrivalent influenza vaccine (QIVc). It will also bolster the company’s formulation capacity, as well as fill and finish manufacturing capacity of cell-based and adjuvanted influenza vaccines.
Construction on the project started in November 2018 and is scheduled for completion in April 2020. Once operational, the facility is expected to generate 120 highly skilled jobs.
The Holly Springs flu vaccine manufacturing facility occupies a 185-acre site in the Holly Springs Business Park situated in the Research Triangle region in Wake County.
The business park is located 22 miles (35.4km) from the Raleigh-Durham International Airport and is designated as a foreign trade zone. It offers companies between five and 50 acres of land ready for development.
The expansion will increase the manufacturing facility’s size to more than 475,000ft². The facility is designed to produce up to 200 million influenza vaccine doses within six months of a declared epidemic.
It uses cell culture-based technology as a substitute for conventional egg-based influenza vaccine production. Cell-culture based vaccines are produced using a candidate vaccine virus isolated and cultured in cells as opposed to eggs. The viruses are grown within mammalian cells inside sterile stainless-steel bioreactors.
The cell-culture technology allows products to be scaled up more quickly in the event of an influenza epidemic.
US-based construction company Fluor was contracted to carry out the expansion of the facility.
The Holly Springs manufacturing plant is a highly automated purpose-built state-of-the-art facility developed in partnership with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to fight epidemic influenza risks.
The facility houses seven buildings linked by a central corridor. It contains a high-speed syringe filling line, formulation, inspection and packaging capabilities. It is the US’s first cell culture-based influenza vaccine manufacturing facility.
In 2014, the US Food and Drug Administration (FDA) licensed the facility for the production of Flucelvax. In 2016, the FDA approved the production of cell-based Flucelvax Quadrivalent vaccines at the facility.
Flucelvax Quadrivalent helps protect against influenza in people aged four years and older. The facility can produce approximately 20 million doses of the Flucelvax Quadrivalent flu vaccine every season.
Seqirus is a subsidiary of CSL, formed following the acquisition of Novartis’ influenza vaccine unit in February 2016 and integrated with CSL’s vaccines division, bioCSL.
The company operates production facilities in the US, UK and Australia. It manufactures influenza vaccines using both egg-based and cell-based technologies.
Seqirus has a wide portfolio of differentiated products marketed in more than 20 countries. The company’s 2018-19 influenza vaccine portfolio includes FLUAD®, Flucelvax Quadrivalent and Afluria® Quadrivalent.
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