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DoD Funding Mobile Vaccine/Therapy Manufacturing Lab

DNAmolcule model

(Skeeze, Pixabay)

8 Oct. 2020. The U.S. Defense Department’s research agency is funding a prototype mobile lab to produce RNA-based vaccines and therapies in the field on demand. The Defense Advanced Research Projects Agency, or DARPA, is awarding $56 million to Moderna Inc. in Cambridge, Massachusetts for a mobile version of the company’s manufacturing facilities.

Moderna develops therapies and protective vaccines against infectious diseases with a technology that synthesizes messenger RNA, a nucleic acid based on the genetic code from DNA, and used by cells to produce amino acids in proteins for cellular functions. Moderna manipulates the coding region in messenger RNA chemistry to provide instructions for cells to produce proteins with specific therapeutic properties.

For therapies, those coding instructions are contained in a standard package that appears in most cases like natural RNA to avoid triggering an immune response, and reach the desired cells where the protein is needed. For protective vaccines, Moderna delivers messenger RNA with instructions for cells to produce proteins with enough resemblance to viruses to generate an immune response, but are still safe for the recipient.

The DARPA award calls for Moderna to create a mobile, end-to-end automated manufacturing lab for mRNA vaccines and therapies. The lab is expected to produce hundreds of doses of vaccines or therapies in the field on demand in a few days. The 6 cubic foot (1.8 meter) container would be deployed to remote areas in the world, yet still meet Good Manufacturing Practice quality standards for pharmaceutical production facilities.

Moderna plans to demonstrate the mobile labs with its Covid-19 vaccine candidate, code-named mRNA-1273 now in late-stage clinical trials, and a cancer immunotherapy in a mid-stage trial. That immunotherapy, code-named mRNA-4157, creates an immune response that attacks targets called neoantigens, unique sets of mutations expressed in cancer patients’ tumors.

“This new award,” says Moderna CEO Stéphane Bancel in a company statement, “will allow us to explore the reach of our technology to potentially enable fast, in-field, automated manufacturing of vaccines and therapeutics for both military personnel and civilians around the world in a container that can be deployed rapidly to make customized vaccines or therapeutics. The ability to make medicines in a mobile unit could have an important impact on the ability to respond to future viral challenges.”

DARPA awarded the funds from its Nucleic Acids On Demand World-Wide program designed to provide countermeasures to high-impact, fast-spreading disease outbreaks from lethal respiratory pathogens. The initiative, begun in 2019, cites previous coronavirus outbreaks SARS and MERS, as examples. The program supports research on upstream processes to speed and improve synthesis of DNA or RNA candidates, as well as end-to-end platforms for manufacturing and quality control.

DARPA is not the only organization looking into mobile production labs for vaccines or therapies. As reported by Science & Enterprise in August, Eli Lilly and Co. is converting recreational vehicles into mobile research labs. The custom-modified mobile units serve as infusion clinics for clinical trial participants, as well as self-contained materials storage and preparation labs. The company plans to deploy the mobile labs as part of a clinical trial testing synthetic antibodies to both treat and prevent Covid-19 infections among people in long-term care.

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