Earlier this week I took a trip to Liverpool (UK) to the Downstream Processing Day hosted by SAFC and Sartorius Stedim Biotech. A lot of interesting topics were discussed, including vaccine manufacture, which is a particularly hot issue both inside and outside of the industry at the moment.

Barely a week seems to have gone by since the start of winter without the mention of flu cases and related deaths in media headlines. Just this week, I’ve seen the following headlines on news sites: Expert calls for routine child flu jabs, Only 12,000 doses of flu vaccine left in Taipei and Flu deaths reach 338 as cases decline figures show.

The great flu debate

So I was very interested in a presentation by Hikmat Bushnaq-Josting, Technical Manager at SAFC, which touched upon flu vaccine manufacture and some of the challenges for industry in this area. When we’re constantly being bombarded with influenza news — much of which isn’t flattering for the bio/pharma industries with companies being accused of exaggerating the threat to increase vaccine sales or criticized for not making enough doses — it’s somewhat refreshing to hear something from the industry’s point of view.

Vaccine manufacturers, like all pharma manufacturers, have a lot to deal with such as cGMP, inspections and so on. Unfortunately, vaccine manufacturers, particularly those involved in pandemic flu vaccine manufacture, have much more to deal with. Firstly, the development of a vaccine often takes much longer than that for other medical products; a vaccine is given to healthy people and so nobody wants to see any risks or serious adverse effects.

One particular issue is demand and supply. Bushnaq-Josting explained that the demand for vaccines — particularly flu vaccines — varies; the prevalence of certain diseases cannot be predicted. Demand also varies depending on how the general population is feeling. For instance, here are some common thoughts from the general population:

“Nobody died from flu last year? We’re not taking the vaccine this year because the vaccine manufacturers are just trying to make money.”

“Lots of people are dying from the flu? We all want the vaccine now!”

Whenever there is a potentially dangerous strain, the situation is also exacerbated by the media with its countless headlines of flu death victims, ultimately leading to widespread panic and greater demand for a vaccine.

When there is demand, it all comes at once, with various manufacturers fighting for supplies and manufacturing capacity — certainly a headache for raw materials’ suppliers and CMOs stuck in the middle of dozens of customers demanding everything all at the same time!

Innovation isn’t easy

As well as the above issues, Bushnaq-Josting also outlined some of the advances being made in the vaccine industry, such a slow shift from eggs to more innovative technologies, such as growing cells in bioreactors. These technical changes may form yet another challenges for the vaccine industry because change is not always easy — particularly in the slow-moving vaccine industry that likes to keep hold of currently working processes.

However, according to Bushnaq-Josting, these changes are gaining momentum and will help processes to be more controlled. To adapt, he recommended that companies direct their attention to cell lines, which will make scale-up easier. Indeed, there are already many different cell lines available on the market, with more to come in the future. There is also a need for more flexible facilities using, for instance, disposable systems.

Alternatively, companies could also look to outsourcing, but there are, of course, many factors that need to be considered in this area too.

All in all, I felt that this was an interesting presentation and, having been bombarded all winter with various shocking headlines in consumer press here in the UK — about flu pandemics, vaccine shortages, government and corporate unresponsiveness — it was useful to hear the manufacturer’s perspective and to better understand the challenges that they face, not only in responding to pandemics and public pressure, but also to innovate.