Seqirus, a business of CSL Limited, today announced the completion of an expansion to the company's manufacturing facility in Holly Springs, N.C., supporting the formulation and fill-finish of its cell-based influenza vaccines in pre-filled syringes for global communities. The new pre-filled syringe line has received FDA approval and will support influenza vaccine production for the 2022/23 Northern Hemisphere season and beyond. Additionally, it will enhance the site's ability to respond to an influenza pandemic. The expansion, which began in 2018, cost $156 million dollars to complete and will support more than 80 additional highly skilled jobs in the Holly Springs community.
The expanded manufacturing facility and new pre-filled syringe line will allow Seqirus to increase its capacity to supply the U.S. market with FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the first and only cell-based quadrivalent influenza vaccine in the U.S. for individuals six months of age and older.1
"According to the World Health Organization (WHO), seasonal influenza can lead to up to 650,000 deaths globally each year," said Steve Marlow, General Manager, Seqirus.2 "As one of the world's leading influenza vaccine manufacturers, we're continuously looking for opportunities to advance capabilities and support efficient, sustained supply of new and existing technologies. Today's milestone is evidence of that commitment."
With this expansion, the Holly Springs facility now has two state-of-the-art fill-finish lines. The new fill-finish line will support more efficient production of FLUCELVAX® QUADRIVALENT. Cell-based influenza vaccines are designed to produce an exact match to WHO-selected influenza virus strains by avoiding egg-adapted changes. In seasons where egg adaptation occurs, studies suggest cell-based vaccines may have the potential to be more effective than traditional, egg-based flu vaccines.
"As demand for differentiated influenza vaccines grows, it is paramount that we expand our manufacturing capacity," said Dave Ross, Vice President, North America Commercial Operations at Seqirus. "This new line gives us the ability to more efficiently streamline our production process, allowing us to better meet the needs of our customers and, in turn, better meet the needs of public health."
FLUAD® QUADRIVALENT, which is specifically developed for adults 65 years and older using the company's MF59® adjuvant, is also produced at the Holly Springs facility.
The Holly Springs manufacturing facility, the largest cell-based influenza vaccine producer in the world and the first-of-its-kind in the U.S., was purpose-built through a public-private partnership established in 2009 with the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). This facility expansion enhances the site's regular seasonal influenza vaccine production, as well as to surge production to respond to a potential influenza pandemic.
The Holly Springs facility is part of Seqirus' global manufacturing and supply network supporting seasonal influenza vaccine production and pandemic preparedness, including sites in Liverpool, UK, Parkville, Australia, as well as a new state-of-the-art facility currently under construction in Tullamarine, Australia.
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