The idea of being able to produce vaccines at the point of care with the push of a button may sound futuristic, but Codex DNA Inc. claims it will have the first fully automated, tabletop vaccine printer ready for the market in 18-24 months.

Will this be a game-changer in rolling out a COVID-19 vaccine? Probably not. But the technology could better position health officials to respond to the next pandemic, or eventually to produce a better, faster influenza vaccine each year.

“If there was a network of 10,000 of these printers, we have the potential to stamp out future pandemics,” Todd Nelson, founder and CEO of San Diego-based Codex DNA, told BioWorld.

For the past several years, the company has been developing its digital-to-biological converter (DBC) platform, which includes the Bioxp 3250 system – a fully automated synthetic biology workstation that measures slightly larger than the average desktop printer.

Nelson said they are about 60% to 70% of the way toward a market launch, with just a few modules still left to complete.

“In a few months we’ll be able to actually make the complete vaccine,” Nelson said.

The next step is to meet with the U.S. FDA about regulatory clearance. Nelson said the platform would go through the same Current Good Manufacturing Practices process used for diagnostic instruments.

Nelson said the company is targeting the price point to be consistent with similar capital equipment in a hospital diagnostic laboratory.

On-demand production

The platform merges advances in synthetic biology with state-of-the art vaccine manufacturing technologies that use RNA or DNA as the basis of the vaccine, said Daniel Gibson, chief technology officer and co-founder of Codex DNA.

“What this really allows for is building biology, which could be vaccines, at a remote location,” he said.

The Bioxp instrument can print viral antigens, clone those into an appropriate expression vector, and assemble the vaccine cocktail. This entire process of vaccine synthesis and delivery takes about 48 hours, compared with nine to 12 months with a traditional vaccine process.

The key is that the vaccine printer is stocked with reagent cartridges containing all the materials needed to build any gene in any genome. Once the DNA sequence of a viral antigen is determined by a vaccine manufacturer and approved by the FDA, it would be sent over the Internet to the network of printer units. Vaccine production could be initiated on demand.

“Every virus has a genome,” Nelson explained. “What the system does is, it just takes those letters in the genome and turns them into real genes. It takes input, which is digital, and it ends up with a biological gene that can then be used downstream in various types of applications.”

Each vaccine printer unit can deliver 100 mg of RNA – or about 500 doses – every 48 hours.

Dynamic vaccines

Since the genomic sequences can be uploaded to the printers immediately after surveillance, the platform would dramatically decrease the time it takes to manufacture vaccines, making it advantageous for producing vaccines that must be administered annually, or for combatting viruses that mutate.

As an example, if COVID-19 were to re-emerge in a few years with a mutated strain in one part of the world, the Codex DNA printer network would be able to rapidly produce a vaccine tailored to that outbreak and potentially contain the virus before it could spread worldwide, Nelson suggested.

Flu is another good example of the customizable nature of the technology.

“Every year there is a one-size-fits-all flu vaccine and for some people in some areas it works well and for others it doesn’t work at all,” Gibson said. “You could have a different flu vaccine being printed for every zip code, if that’s what was needed.”

One in every pharmacy?

Codex DNA’s ultimate goal, Nelson explained, is to have a vaccine printer in every hospital, pharmacy, and doctor’s office, so that vaccines could be printed on demand at the point of care. But the company isn’t quite ready to roll out at that level yet.

Over the next year, they will be working with vaccine manufacturers to use the printer in their internal process. Once the printer technology is approved, Codex DNA plans to move its platform into hospitals and eventually to pharmacies. Gibson said he could also see a role for governments placing the printers at strategic locations.

Codex DNA isn’t the only company working on a vaccine printer. The German-based biopharmaceutical company Curevac AG has partnered with the Coalition for Epidemic Preparedness Innovation to develop a transportable automated messenger RNA printing facility. The venture was originally targeted at Lassa Fever, Yellow Fever and Rabies, but with the emergence of COVID-19, the company is now looking to use the vaccine printer against that virus. Curevac recently teamed up with Tesla Inc. on the venture. Tesla CEO Elon Musk confirmed the partnership over the summer on Twitter, noting that Tesla Germany had designed and built the vaccine RNA printers for Curevac.

The Curevac technology is different from what Codex DNA is preparing to market, Gibson said, noting that it is not a fully integrated solution that starts at the point of the digital DNA sequence.

“It’s certainly not a competition,” Nelson said. “Whoever can crack this puzzle is doing a great job. It’s about working together, too, and we want to work with even our competitors to bring enabling solutions to the world right now that can help stop future pandemics.”

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