Seqirus Produces Cell-Based Influenza Vaccine at Commercial ScaleBy
Seqirus, a developer and manufacturer of influenza vaccines, has produced a cell-based influenza vaccine at commercial scale at its manufacturing facility in Holly Springs, North Carolina.
Seqirus is part of CSL Limited, headquartered in Melbourne, Australia. Seqirus was formed in 2015 following CSL’s $275-million acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL, a CSL subsidiary. The acquisition included Novartis influenza vaccine manufacturing facility in Holly Springs. That facility was built with a total investment of approximately $1 billion through a partnership between Novartis and the US Department of Health and Human Services to support the design, construction, validation and licensing of the manufacturing facility in Holly Springs for pandemic influenza vaccines.
In producing the cell-based influenza vaccine, Seqirus used a candidate vaccine virus (CVV) that was isolated and grown in cells rather than in eggs. CVVs are prepared by the World Health Organization (WHO) Global Influenza Surveillance and Response System and associated laboratories and are used by manufacturers to develop and produce influenza vaccines.
The use of cell-derived CVVs has the potential to drive improved process control and increased output in the production of cell-based influenza vaccines. Also, influenza viruses isolated and grown exclusively in cells can be more similar to influenza viruses in circulation, according to information from Seqirus.
Since first beginning production in 2014, the Holly Springs site has used egg-derived CVVs in its cell-based manufacturing process. In 2016, the WHO began to also recommend cell-derived CVVs, and the US Food and Drug Administration issued an approval for Seqirus to use them in the production of cell-based influenza vaccines at the Holly Springs facility. The company plans to utilize cell-derived CVV technology for the production of other vaccine strains produced at the Holly Springs site in the future.
The Holly Springs facility was purpose-built in partnership the US Biomedical Advanced Research and Development Authority to help combat pandemic threats. Novartis received FDA approval to manufacture cell-based influenza vaccine at the Holly Springs facility in 2014.
This latest milestone by Segirus is the result of a multi-year collaboration involving the WHO Collaborating Center for Surveillance, Epidemiology and Control of Influenza at the US Centers for Disease Control and Prevention, the WHO Collaborating Center for Reference and Research on Influenza in Melbourne, Australia, and scientists at Seqirus and Novartis, its predecessor company. The cell-based H3N2 CVV used by Seqirus was developed by the WHO Collaborating Center in Melbourne from a sample originally obtained from the National Influenza Center in Singapore.