Seqirus receives FDA approval on cell-based flu vaccine manufacturing process

11-Sep-2018 - Last updated on 08-Aug-2019 at 18:13 GMT

(Image: Getty/Pornpak Khunatorn)

Related tags Flu vaccine Cell biology Manufacturing Fda

Seqirus received approval on its cell-based flu vaccine manufacturing process from the FDA, not long after its FY18 earnings showed profitability.

Seqirus is the manufacturer of Flucelvax Quadrivalent. The US Food and Drug Administration (FDA) gave its approval on a cell-based manufacturing process for the influenza vaccine, enabling Seqirus to double its current production levels.

The company’s full year results for 2018 show more than a $300m or roughly €259 turnaround which has been attributed to the scale up of the cell-based technology the company acquired from Novartis in 2015. Seqirus went from producing 3 million doses a year in 2015 to producing 20 million doses per season last year.

Manufacturing takes place at the company’s Holly Springs, North Carolina facility, which it acquired after taking over the cell-based flu vaccine project from Novartis. The facility was originally built alongside the US Biomedical Advanced Research and Development Authority (BARDA).

Gordon Naylor president of Seqirus told us that the facility is what allows for being able to produce with a scalable method, “With this FDA approval we’ll go to 40 million doses. So that’s really big increases in production and that’s what so exciting here is that we’re actually about to produce the vaccine in large quantities. It’s quite a breakthrough for us to be able to do that.”

Cell-based vaccine specificity

Since producing vaccines for the flu season of 2017/2018 data became available showing that cell-based technology as a whole was associated with better hospital outcomes than standard influenza vaccine options.

Naylor attributed the improved outcomes as an attribute of cell-based vaccines since they can be grown in cell cultures as opposed to the traditional chicken eggs, making them easier to modify if the predicted strain changes.

“When manufacturers and the World Health Organization (WHO) decide on which strain to manufacture, we all need to be very confident that that strain will grow in eggs and it might be exactly the same [strain] that is out there in the world, that is threatening the public, but if it doesn’t grow in chicken eggs it’s not feasible to protect the population [based upon standard manufacturing techniques],” he explained.