Vaccine manufacturing facility expansion
Seqirus, a biotherapeutics company based in Australia, announced plans to expand its flu vaccine manufacturing facility located in Holly Springs, North Carolina, US, in November 2018.
The $140m expansion will enable 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. The new facility is expected to generate 120 highly skilled jobs once it begins operations.
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, North Carolina, US.
The business park is located 22 miles (35.4km) away 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 the conventional egg-based influenza vaccine production. Cell-culture based vaccines are produced using a candidate vaccine virus, which is isolated and cultured in cells, rather than in eggs. The viruses are grown within mammalian cells inside sterile stainless-steel bioreactors.
The cell-culture technology enables faster scale-up of products in the case of an influenza epidemic.
Fluor was contracted to carry out the expansion of the Holly Springs flu vaccine manufacturing facility.
The Holly Springs manufacturing plant is a highly automated purpose-built state-of-the-art facility developed 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 first cell culture-based influenza vaccine manufacturing facility in the US.
The US Food and Drug Administration (FDA) licensed the facility for the production of Flucelvax in 2014. The FDA approved the production of cell-based Flucelvax® Quadrivalent vaccines at the facility in 2016.
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 bioCSL, the vaccines division of CSL.
The company operates production facilities in the US, UK, and Australia. It manufactures influenza vaccines using egg-based, as well as cell-based technologies.
Seqirus has a wide portfolio of differentiated products, which are 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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