mRNA printers kick-start personalized medicines for all - Nature Biotechnology

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mRNA printers kick-start personalized medicines for all - Nature Biotechnology
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mRNA printers kick-start personalized medicines for all - Cormac_Sheridan

South Africa is setting up mRNA manufacture with new technologies that will ensure vaccines and therapeutics can be made locally and cheaply. Cape Town–based Afrigen joined forces with Belgian firms Univercells and eTheRNA. And the US-based Greenlight Biosciences is about to start a clinical trial of an mRNA vaccine in South Africa, to test a vaccine that will cost about $1 per dose—a fraction of the price of other mRNA vaccines.

Yet mRNA manufacturing has not kept pace with innovation—companies often rely on “antiquated approaches,” Singhvi says, as they have neither the time nor the resources to invest in better alternatives. At best, they are adding incremental improvements to out-of-date processes, and “that’s never going to move the needle.” Resilience has raised over $2 billion in equity financing and has big ambitions to put biomanufacturing on a similar footing to semiconductor manufacturing.

Dan Gibson, chief technology officer at Codex DNA, argues that this is already a reality in research settings. While he was at Synthetic Genomics, Gibson and colleagues, including J. Craig Venter, developed an automatedto produce nucleic acids and proteins directly from DNA sequence information. Codex DNA was later spun out to commercialize the technology.

To be fit for the clinic, mRNA molecules generated in this fashion will need regulatory blessing. Upcoming discussions with the US Food and Drug Administration about the company’s first investigational new drug filing, for NTX-0250, an RNA therapeutic targeting herpes simplex virus–driven cancers, will therefore have an important bearing on the technology’s immediate future.

Key to the Africa-wide initiative is a highly automated, low-cost manufacturing platform, which Charleroi, Belgium–based Univercells has developed with the help of funding from the Bill and Melinda Gates Foundation. Its cell-free production platform involves capital expenditure and running costs that are a fraction of those needed for current approaches.

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