Massachusetts-based Landmark Bio has secured an ARPA-H award of up to USD 18.3 million to develop a continuous manufacturing platform for extracellular vesicle therapies, with the program designated TRANSFORM EV. The contract, administered through ARPA-H's Scalable Solutions Office, will fund two sequential phases covering process and analytical development, followed by pilot-scale implementation.

Landmark Bio, an Artis BioSolutions company, will lead the work with a subaward to MIT. Principal investigator Gregg Nyberg, who also serves as the company's chief technology officer, will oversee a scope that includes upstream production, downstream purification, fit-for-purpose analytics, and process modeling for end-to-end continuous operation.

The award reflects federal interest in resolving manufacturing bottlenecks that have slowed extracellular vesicle programs across the industry, including low yields, variable product composition, and limited scalability. The ARPA-H Scalable Solutions Office, led on this project by program manager Daria Fedyukina, targets cost and access barriers in healthcare manufacturing more broadly.


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