Seqirus


Seqirus At The Forefront Of Advancements In Cell-Based Technology

The introduction of cell-based influenza vaccine technology represented one of the most significant advancements in the history of influenza vaccine production. Seqirus recently announced the next major advancement in the use of this technology at its state-of-the art manufacturing facility in Holly Springs, North Carolina, US.

Twice each year, the World Health Organization (WHO), the five WHO Collaborating Centers (including the Centers for Disease Control (CDC)) and their public health partners collaborate on the preparation of Candidate Virus Vaccines (CVVs); influenza viruses that are provided to manufacturers prior to every season for the production of influenza vaccines.

Because egg-based technology has been used to manufacture influenza vaccines for more than 70 years, CVVs have traditionally been derived from eggs. As such, only egg-derived CVVs have been available to Seqirus for use in the cell-based influenza vaccine manufacturing process at Holly Springs, US, – up until now.

Last year, the WHO began to also recommend cell-derived CVVs and the US Food and Drug Administration (FDA) issued an approval for Seqirus to use these CVVs in the manufacture of its influenza vaccines. In an industry first, Seqirus used a cell-derived H3N2 CVV in the production of FLUCELVAX QUADRIVALENT®, quadrivalent influenza vaccine, for the 2017/2018 Northern Hemisphere season, making the production of this particular strain exclusively cell-based.

The process of creating cell-based influenza vaccines involves several steps. Following the WHO’s recommendation of CVVs for distribution, Seqirus inoculates the CVVs into cultured mammalian cells, instead of into eggs, and allows them to replicate. The virus-containing fluid is collected from the cells, the virus antigen is purified, and the manufacturing process continues with formulation and testing. Finally, the vaccines are packaged and approved prior to release and shipment.

Cell-derived CVVs, rather than egg-derived CVVs, are better suited to the Holly Springs manufacturing platform and their use has the potential to increase influenza vaccine output at the facility. Additionally, cell-derived CVV’s may be more similar to circulating viruses than egg-derived CVVs, potentially improving the effectiveness of the vaccine.

Seqirus plans to use cell-derived CVVs for the production of other vaccine strains produced at Holly Springs in the future. The application of this promising technology is part of Seqirus’ leading role in influenza prevention and reflects the deep expertise that exists within Seqirus, developed throughout 100 years of influenza experience. It will improve our overall production process and enhance our ability to deliver on our commitment to public health.

The Holly Springs facility was purpose-built in partnership with the US Biomedical Advanced Research and Development Authority (BARDA) to help combat pandemic threats, and this latest milestone is the result of a multi-year collaboration involving the WHO Collaborating Centre for Surveillance, Epidemiology and Control of Influenza at the US Centers for Disease Control and Prevention (CDC), the WHO Collaborating Centre for Reference and Research on Influenza in Melbourne, Australia, and scientists at Seqirus. The cell-based H3N2 CVV used by Seqirus was developed by the WHO Collaborating Centre in Melbourne, Australia, from a sample originally obtained from the National Influenza Centre in Singapore.

This major advancement would not have been possible without significant global collaboration, and is a fine example of how industry and public health agencies can work together to enhance the global influenza surveillance and response system.