In a mountain valley in the Swiss Alps, new production lines are spinning up to produce the key ingredient for hundreds of millions of doses of Moderna’s COVID-19 vaccine, which the Food and Drug Administration approved for emergency use in the U.S. on December 18. This type of factory would normally take years to build. But Lonza, the manufacturer, used a new approach that made it possible to finish the work in months.
Two years ago, the company invested in a new concept for pharma manufacturing: Instead of building a new factory for a specific vaccine or drug, it started creating shells of buildings that could be adapted quickly for different purposes while also meeting all the strict requirements for this type of facility.
“In this pandemic situation, we are working around the clock to set up manufacturing in around eight months, compared to the two or more years it would usually take,” says Torsten Schmidt, who is leading the production facility in Switzerland. The company built empty buildings and preemptively hooked them up to central infrastructure to supply sterile water, steam, gas, and other utilities necessary for bioproduction.
“The empty shells allow us to drop in the manufacturing technology that is needed for a particular drug or vaccine,” Schmidt says. “This is important given that vaccines and drugs are becoming more diverse and a facility for one drug or vaccine cannot be easily used for another type of molecule.”
By creating the basic infrastructure in advance, the company was able to move particularly quickly after it signed a 10-year contract in the spring to produce ingredients for Moderna’s at-the-time unproven vaccine. Even with the head start, the process was still a sprint, with a team working around the clock to get three new production lines ready, at a cost of $210 million, along with a single production line at the company’s U.S. facility in New Hampshire.
It’s one step in a series that has made it possible to begin vaccinations in record time. Moderna had been working with partners at the National Institutes of Health on a new type of vaccine platform—mRNA—for years before the COVID-19 outbreak began. BioNTech, which later partnered with Pfizer, was working on the same type of platform.
The technology works by copying a snippet of the virus’s genetic code and then inserting it into the body. While traditional vaccines require growing vats of cells inside a factory (for example, growing an inactivated version of a virus), mRNA vaccines essentially turn the body into a mini factory itself. When your body uses the genetic instructions to make a tiny piece of the virus, the “spike” protein that the virus uses to invade cells, your body learns to recognize the invader, so if you’re later in contact with the real virus, you’re ready to fight it off.
Because it already had established the basic approach for mRNA, Moderna was able to act in record speed in January: Days after a network of other researchers released the genetic code for the virus, it had formulated the new vaccine. Vaccines often take as long as a decade to develop, but the first volunteer was injected with Moderna’s on March 16. In May, Moderna signed a deal with Lonza, one of a handful of partners that will manufacture the vaccine at scale. By July, Lonza had started small-scale production at its New Hampshire facility, where it repurposed another manufacturing line.
The larger facility in Switzerland, which will help Moderna supply governments in Europe and Canada, began some production in November and expects to be running at large capacity by the end of the year. Lonza makes the key active ingredient, the mRNA encapsulated in a lipid, and then sends it to what the pharma industry calls a “fill and finish” factory to formulate the final vaccine and put it into vials.
Pfizer, the manufacturer of the other vaccine approved for COVID-19 in the U.S., recently said that it’s on track to produce 1.3 billion doses of its vaccine next year; because the vaccine requires two doses, it will be enough for 650 million people. Each of Lonza’s production lines will be able to make ingredients for 100 million doses of Moderna’s vaccine in a year, or 400 million in total. Along with its other manufacturing partners, Moderna expects to make 500 million doses next year, enough for 250 million people. That’s obviously a smaller number than Pfizer, but every dose is critical when the majority of the global population needs to be vaccinated.