Producer

CSL Seqirus

HQ AU · Melbourne, Australia (US operations: Holly Springs, NC)website ↗

World's largest cell-based influenza vaccine manufacturer; Holly Springs, NC facility produces 150 million flu doses/year and is US government-designated pandemic-ready. Also sole producer of MF59 adjuvant used in pandemic flu and aging-population flu vaccines.

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  • Seasonal Influenza Vaccines

    65%
  • MF59 Adjuvant Technology

    12%
  • US Pandemic Preparedness (BARDA)

    15%
  • Other Vaccines & Pipeline

    8%

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  • Did you know2020

    The US government's pandemic influenza response plan depends on MF59 adjuvant — a product made only by CSL Seqirus, from squalene sourced primarily from deep-sea shark liver oil. MF59's adjuvant effect allows 4× fewer doses of flu antigen per immunization (antigen sparing) — critical when pandemic flu antigen supply is the bottleneck. In a severe H5N1 or novel influenza pandemic requiring 1 billion adjuvanted doses, the squalene supply chain becomes existential: shark-derived squalene is produced globally at roughly 1,000-2,000 metric tons/year for all pharmaceutical uses. Scaling to pandemic volumes would require catching tens of millions of deep-sea sharks — causing rapid population collapse of deepwater shark species that reproduce slowly (~10 years to maturity). Seqirus and other adjuvant manufacturers have been developing plant-based squalene alternatives (amaranth, sugar cane fermentation), but as of 2024 the transition is incomplete.

    The Shark Trust
  • Capacity2023

    CSL Seqirus operates the only US government-designated pandemic flu manufacturing surge facility — the Holly Springs, NC plant built with $2.5B+ in BARDA investment. The plant is designed to produce 150 million cell-based flu vaccine doses within 4 months of pandemic declaration. This is the foundational assumption in US pandemic preparedness plans: one plant, one company, 150M doses. The plant was designed to be egg-independent, eliminating the vulnerability of traditional egg-based flu manufacturing (which requires ~100M fertilized eggs for full-scale seasonal production, and which would be disrupted by any concurrent avian influenza outbreak that forced poultry culls). In a severe H5N1 pandemic with concurrent poultry mass culls, egg-based flu vaccine capacity would collapse at exactly the moment when pandemic flu vaccines are most needed — making the Holly Springs cell-based facility the single surviving US flu vaccine manufacturing capacity.

    US Dept. of Health and Human Services / BARDA
  • Origin2023

    CSL Seqirus was formed by CSL Limited's 2015 acquisition of Novartis Vaccines (for $275M) — which included the MF59 adjuvant patent portfolio and the Holly Springs, NC plant, originally built as a $1B+ US government-backed pandemic preparedness facility. Novartis had built Holly Springs under a BARDA contract specifically to create a US-based, egg-independent surge manufacturing capability for pandemic flu. CSL also acquired bioCSL (Australia) in 2014. The combination created a company that is simultaneously: the world's largest cell-based flu vaccine manufacturer, the sole producer of the MF59 adjuvant, and the designated US government pandemic flu surge facility. CSL parent also produces plasma biologics (CSL Behring) and iron deficiency drugs (CSL Vifor) — one of the few companies with significant positions in three separate critical healthcare supply chains.

    Seqirus (CSL Limited)