NEW YORK – A new program backed by Wellcome Leap, the US nonprofit founded last year by the UK’s Wellcome Trust, will lay the foundation for a series of new, RNA-based biofoundries to support access to diverse biologics, including mRNA vaccines and monoclonal antibodies.
The effort, called RNA Readiness + Response, or R3, commenced last month with a budget of $60 million, partially funded by the Coalition for Epidemic Preparedness Innovations, a Davos, Switzerland-based partnership focused on vaccine development. The program is expected to aid increased investments in RNA-based products, which the organizers maintain are currently limited by manufacturing constraints.
According to Duccio Medini, R3’s program director who previously worked in vaccine research and development at GlaxoSmithKline and Novartis, every new RNA product currently requires developing a new process.
“There is no standardized platform” for manufacturing RNA products, he said. “If you want to do a certain vaccine, you have to reinvent the process. Then if you want to do another vaccine, you have to redo the process, get it reapproved by regulators, spend more to stand up a manufacturing line, and do the tech transfers.”
According to Medini, R3 is not directly applicable to genomics, but rather will serve to help realize discoveries made by genomic researchers and translate those into products. One example is RNA vaccine development, spurred by the global uptake of Moderna and Pfizer’s mRNA-based vaccines during the ongoing COVID-19 pandemic.
Wellcome Leap anticipates there will be a wave of activity to discover, develop, and deliver new RNA-based biologics, Medini said, and that various organizations from academics to biotechs to research centers will soon need reliable, scalable biofoundries to manufacture them so they can be tested against existing and emerging diseases.
According to Medini, R3 has three strategic elements. One is to build a global platform to produce RNA-based biological products. A second is using digital data science to make the design and development of new RNA-based products accessible to all developers via a simulation platform. This would allow anyone from academic researchers to scientists at pharmaceutical companies to design such products, he said. A third aim is to establish clinical-grade manufacturing capacity to allow products designed on the simulation platform to be immediately manufactured.
While these aims would suggest either establishing a commercial entity to handle manufacturing or partnering with an existing foundry, Medini said that R3’s aims are independent of what organization or company does the manufacturing. “The foundries could be owned by contract manufacturing organizations or by vertically integrated companies or newer entities that take a pure-play business model,” he said. “The important thing is that there is a standardized process.”
R3 is expected to run for three years. By the end of the program, Wellcome Leap hopes to have a physical foundry in place that can manufacture multiple products on the same standardized platform. The technology should also be capable of being replicated elsewhere using the same processes. “We want these capabilities to be easily deployable to where the products are needed,” Medini said.
The application areas are not limited to human health. RNA-based pesticides have been developed and approved by the US Environmental Protection Agency in recent years, for instance. “RNA is such a versatile molecule that we envision a broad usage of the same underlying manufacturing technology in a diverse slate of products,” he said.
Medini did not say what specific technology would be used to achieve the aims of R3 but mentioned self-amplifying RNA as a promising technique.
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