Thursday, June 22, 2017
Seqirus, a leading innovator in influenza vaccines and pandemic preparedness, today announced the next major advancement in the use of cell-based technology at its state-of-the art manufacturing facility in Holly Springs, North Carolina.
In an industry first, Seqirus has successfully produced cell-based influenza vaccine at commercial scale using a candidate vaccine virus (CVV) that has been isolated and grown in cells, rather than in eggs.1,2 CVVs are prepared by the World Health Organization (WHO) Global Influenza Surveillance and Response System (GISRS) and associated laboratories, and are used by manufacturers to develop and produce influenza vaccines.
The use of cell-derived CVVs, rather than egg-derived CVVs, has the potential to drive improved process control and increased output in the production of cell-based influenza vaccines. In addition, influenza viruses isolated and grown exclusively in cells can be more similar to influenza viruses in circulation.3,4
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 (FDA) issued an approval for Seqirus to use them in the production of cell-based influenza vaccines at Holly Springs.4,5
This year, Seqirus was successful in using a cell-derived H3N2 CVV in the production of its cell-based seasonal influenza vaccine, making the end-to-end production of this particular strain exclusively cell-based.1 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.
“Cell-based influenza vaccines represent one the most significant advancements in the history of influenza vaccine production. Seqirus is proud to continue to innovate this promising technology as part of our leading role in influenza prevention and pandemic preparedness,” said Gordon Naylor, President of Seqirus.
“The successful application of this new technology reflects the deep expertise that exists within Seqirus, developed over our 100-year heritage in influenza. 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 the U.S. Biomedical Advanced Research and Development Authority (BARDA) to help combat pandemic threats.6,7 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 U.S. Centers for Disease Control and Prevention (CDC), the WHO Collaborating Centre for Reference and Research on Influenza in Melbourne, Australia, and scientists at Seqirus and its predecessor company. The cell-based H3N2 CVV used by Seqirus was developed by the WHO Collaborating Centre in Melbourne 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 better combat influenza,” said Naylor.
