Why producing a vaccine is no smooth sailing
January 11, 2021Many people breathed a sigh of relief when they heard that a German company was among the first to develop a vaccine against COVID-19. They were proud of Mainz-based BioNTech.
It didn't take long, though, before that relief gave way to skepticism and many questions concerning post-approval procedures. Who should be vaccinated first? Would there be a fixed order and above all, would enough doses of the vaccine be available in time?
It's not enough to buy a firm
Rolf Hömke, a spokesman for the German association of pharmaceutical research companies (vfa), which represents close to 50 German pharma firms, points to a major challenge. "It's one thing to get production going on a small scale, but having to scale up production quickly is another," he said.
BioNTech rose to the task by buying an additional production facility in Marburg from its competitor Novartis. The facility was fully equipped and had a skilled workforce. It also had equipment to cultivate bacteria and cleansing technology. But, Hömke says, it still wasn't quite what BioNTech needed for its specific tasks.
The Marburg staff had to be retrained to adjust to the new challenges. "Technology is one thing, but you also need experienced employees, so we had to train them accordingly," Hömke said. BioNTech says production in the Marburg plant could start as soon as February.
One of the two founders of BioNTech, Ugur Sahin, who co-developed the vaccine, told the Der Spiegel magazine that the production of mRNA vaccines was anything but smooth sailing. "You cannot switch from producing aspirin or cough medicine to vaccines just like that," Sahin said. "You need many years of expertise in the field and adequate technological equipment."
Not a question of technology
But it's not so much about a lack of machinery. The German Engineering Association (VDMA) told DW it hadn't noticed any increase in demand for machines among its member firms from the pharmaceutical industry, suppliers or hauliers tasked with transporting vaccines.
What's become obvious, though, is that you can't go it alone. To develop a new active agent or vaccine is usually a task for a small teams of highly specialized researchers. Aided by large research institutions, they're able to produce enough vaccine for clinical testing and approval.
Bu they can't supply much more than that. Even large companies need help from others, according to Hömke. "In the pharma industry, they always depend on suppliers," he pointed out, adding that you also need bacteria cultures and nutrient solutions plus a number of specialty chemicals.
Glass from Mainz
Some of these suppliers have had extreme success amid the pandemic. Take the makers of vials, for instance. The vaccines require a special glass quality for storage. A number of properties are required. For BioNTech's vaccine, it's important that the vials are temperature-resistant and that the glass doesn't have any chemical reaction with the substances it holds.
Such a borosilicate glass quality has been produced by the Mainz-based Schott company since 1887. Today, Schott is among a group of three firms dominating the global borosilicate glass market, alongside Stevanato of Italy and Gerresheimer from Düsseldorf, Germany.
SMEs with global reach
Some 120 years ago, Gerresheimer was among the world's largest glass-making companies. Nowadays it produces glass predominantly where its customers are located. Two plants in the US and Mexico produce vials for the North American market. There are also three facilities in China and one in India. The European market is catered to by its plants in Chalon, France and Boleslawiec, Poland, with another one in Bünde in western Germany that looks after the German market specifically.
The Financial Times says the German success in the development of a vaccine can be attributed to the nation's economic structure and above all the crucial role of small- and medium-sized enterprises (SMEs).
It says these relatively small firms are able to quickly adapt to new challenges — much quicker than large enterprises. The newspaper also cites the close ties between research, development and production as well as the SMEs' global reach.
Eyeing mass production
The expansion of production capacities will no doubt be crucial, but it will not be the only factor determining just how fast vaccine doses can be supplied to people around the world. "The speed of vaccination campaigns will hinge on how many additional vaccine providers will be added," Hömke said. "A single company cannot provide enough to satisfy global demand in a reasonable timespan; that's simply out of the question."
His assessment is echoed by BioNTech's Ugur Sahin. "We'd be heading toward a supply gap should we not get approvals for other vaccines," he said.
BioNTech, and German researchers along with it, have made a splash globally with their work. Their success may indeed be a result of Germany being a decent location for R&D and the resourcefulness and innovative power of its SMEs.
Vfa's Rolf Hömke says global efforts to kick off mass production of vaccine doses in such a short time are remarkable. "It sure has required many experienced people putting in a great many hours of hard work to get the job done," he said.
Reacting to current criticism in Germany that not enough doses are available at this point in time, Hömke insists that what will be decisive in the end will be the speed at which people get vaccinated in the various centers being set up across the country.
Adapted from German.