Lots of pressure. Lots of hours
[ by Dawne Belloise ]
Thanks to the contribution of Crested Butte Community School graduate Ben Arwood-Levine, the COVID-19 vaccine is more effective and safer. Levine is the senior chemist and team leader working for Corden Pharma, a contract development and manufacturing organization (CDMO) of Boulder, Colo. The company makes drugs for other companies, both large and small pharmaceutical companies.
Levine’s project was to purify the vaccine. “We’re working with Moderna, making the lipid part of the vaccine. The lipid acts as a delivery vehicle, delivering the messenger mRNA into the body,” explains Levine, who many weeks worked 60 or 70 hours on the project.
Once delivered, it tells the body to create the spike protein, which then enables the body to create antibodies to fight the virus.
But just what is this mRNA? The Moderna website describes the function of mRNA (messenger ribonucleic acid) which is unlike traditional pharmaceuticals that are made of small molecules, or even traditional biologics (recombinant proteins and monoclonal antibodies). mRNA medicines are sets of instructions that direct cells in the body to make proteins to prevent or fight disease.
It’s basic human biology. The website explains, “DNA [deoxyribonucleic acid] is a double-stranded molecule that stores the genetic instructions your body’s cells need to make proteins. Proteins, on the other hand, are the ‘workhorses’ of the body. Nearly every function in the human body—both normal and disease-related—is carried out by one or many proteins. Without mRNA, your genetic code would never get used by your body. Proteins would never get made and your body wouldn’t—actually, couldn’t—perform its functions.”
The vaccine project was dubbed Operation Warp Speed by the government. Levine was under extremely high pressure, working consistently long hours on the project. They started working on it in late February after China sequenced the virus DNA in January. Levine says, “So Moderna, being a company that deals in protein vaccines, actually developed this vaccine in two days.” He adds that this was because they had been developing a vaccine for SARS COVID-1 and COVID-19 is actually called COVID-2. “My company has been helping Moderna develop the lipid for four years. The lipid is the critical component. The vaccine won’t function without it.”
Once China published the DNA, Moderna took that and developed the mRNA, which is a genetic fragment. “The upstream chemistry is basically the synthetic portion where they make the lipid from scratch. I do the downstream chemistry, which entails final purification and isolation. The reason why there’s a final purification is that the quality or purity is critical to the proper function of the vaccine,” Levine says.
The vaccine has to be stored at temperatures even colder than a Gunnison Valley winter and Levine says, “There’s quite a bit of storage difference between the Pfizer and Moderna vaccines. The Pfizer vaccine has to be stored at -80°C (-112°F) and Moderna’s is -20°C (-4°F). The difference is because the actual lipid being used by Moderna is a more stable and pure lipid, which stabilizes the mRNA.” He says that the mRNA itself is not very stable and will break down. However, the lipids stabilize it. “That’s the key difference between the two vaccines.”
There’s another process that goes into making the vaccine—formulation. Levine once again explains. “Formulation is everything that goes into it and combining it, which is done by another company,” he says. A lot of the funding for the vaccine development went to clinical trials, Levine says, “because it’s very expensive, especially when you have to do it this fast. Ultimately, it will turn into distribution. Our estimates, as of now, are that we’ve produced the equivalent of 100 million to 200 million doses.”
As far as distribution of the vaccine, he says, “They’re focusing mainly on health care workers and the elderly,” and he chuckles a bit at the reality that neither he nor his team have gotten the shot themselves yet. “It’s pretty funny—the government now has the distribution under their control and they didn’t show preference to giving it to the scientists and chemists working on it.”
The vaccine began shipping last week and Levine is enthusiastic about it, “I will definitely get it and I’m excited. I’m not concerned at all. There’s been a lot of good graces going around.” Of his team he says, “Everyone’s feeling a little bit more relaxed since we have production going.”
As a scientist and a chemist, Levine gets a good feeling from the opportunity to create something of such immense historical significance to save human lives. “It’s been really exciting and the importance of the contribution I’ve made with this vaccine is now just finally starting to set in,” he says. “I wasn’t enjoying it at first because it was really stressful but now the hard work is paying off. The faster we can individually get the vaccine and build herd immunity, the faster we can get back to our lives.”