In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|April 17, 2019
Seqirus to Manufacture Flu Vaccine Using Cell-Based Production Processes
Author(s)BioPharm International Editors
Seqirus has taken the decision to make its cell-based flu vaccine, FLUCELVAX TETRA, using a completely cell-based production process.
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Influenza vaccine provider, Seqirus, announced in an April 15, 2019 press release that it has taken the decision to make its cell-based flu vaccine, Flucelvax Tetra, using a completely cell-based production process.
The company will support its decision to use cell-based candidate vaccine viruses (CVVs) for all four strains recommended by the World Health Organization (WHO) by submitting data to the European Medicines Agency (EMA). This data submission will form part of the 2019/2020 annual strain update requirement.
Each season WHO’s Global Influenza Surveillance and Response System (GISRS) and associated laboratories provide the CVVs from which manufacturing seeds are produced. Large quantities of virus are then grown from the manufacturing seeds, either in eggs or cells, so that sufficient quantities of flu vaccine can be produced that match the WHO-recommended strains. According to a
“Egg-based vaccines are the standard of care and continue to play a critical role in the fight against influenza, but it’s important to continuously evolve approaches to vaccine development,” said Gordon Naylor, president of Seqirus, in the press release. “While we continue to manufacture and distribute egg-based vaccines globally, cell-based influenza vaccines represent a significant advancement in influenza protection. Seqirus is proud to continue to innovate this promising technology as part of our leading role on the front line of influenza prevention and pandemic preparedness.”
In the United States, Seqirus received FDA approval to use cell-based CVVs in the production of cell-based influenza vaccines from 2016, and the company incorporated a cell-based H3N2 CVV in Flucelvax for the 2017/2018 season and cell-based CVVs for both B strains in the 2018/2019 season. Additionally, in the 2019/2020 season, the company will incorporate the remaining A strain, transitioning to an exclusively cell-based product. Seqirus is now preparing to launch its cell-based flu vaccine product in Europe for the forthcoming season.
“We’ve taken a stepwise approach to the introduction of this latest advancement to our cell-based technology, enabling us to continue to scale up manufacturing at [our] Holly Springs [facility in North Carolina, USA]. It will help us to fully realize the potential of our cell-based technology and enhance our ability to deliver on our commitment to public health,” added Naylor.
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