Award will expand Landmark Bio's capabilities in advanced manufacturing, analytics, and process control for biotech and pharma partners

Landmark Bio, an Artis BioSolutions company dedicated to accelerating the translation of next-generation advanced therapies from discovery to clinical and commercial production, today announced that it has secured an Advanced Research Projects Agency for Health (ARPA-H) award totaling up to $18.3 million to build an efficient, robust, and scalable continuous manufacturing platform for extracellular vesicles (EVs). The TRANSFORM EV project aims to address unmet needs in drug delivery by overcoming barriers to commercialization and broadening patient access to transformative EV-based therapeutics. This will be accomplished by establishing advanced domestic manufacturing capabilities that overcome the limitations of current low-yield, high-cost processes.

Extracellular vesicles are gaining recognition as a promising therapeutic and delivery modality, with potential to support next-generation genetic medicines and non-viral delivery approaches. However, across the field, progress is often limited by the same practical hurdles, including low productivity, variable product composition, difficult separations, limited measurement and characterization tools, and the challenge of scaling manufacturing while maintaining consistency. These barriers slow development timelines, raise costs, and make it harder to translate encouraging preclinical results into clinical-grade products.

With this award with ARPA-H, an agency within the U.S. Department of Health and Human Services (HHS), Landmark Bio will work to remove those barriers by developing a scalable manufacturing platform that connects state-of-the-art technologies for upstream production, downstream processing, and fit-for-purpose analytics into a continuous workflow. Traditional batch manufacturing facilities capable of treating a few thousand patients can take up to five years to build at a cost exceeding $450 million. This project aims to reduce manufacturing footprint by up to 10x, reduce costs by up to 10x, and reduce manufacturing lead time. ARPA-H Program Manager Daria Fedyukina, PhD leads this project for the agency under the Scalable Solutions Office (SSO), which is focused on enhanced access and affordability through scaling manufacturing of healthcare technologies and interventions.

“The TRANSFORM EV project will enable us to unlock the true potential of extracellular vesicles as a therapeutic modality,” said Gregg Nyberg, PhD, project Principal Investigator and Chief Technology Officer at Landmark Bio. “Drug developers need partners who can innovate in manufacturing and analytics, not just run standard processes. The contract allows us to help our biotech and pharma partners develop EV programs with greater control, consistency, and a clearer path to scale.”

“Securing this ARPA-H award is a meaningful milestone for Landmark Bio and for Artis BioSolutions," said Brian Neel, Chief Executive Officer of Artis BioSolutions. "It validates our strategy of investing in innovative modalities and differentiated manufacturing capabilities, perfectly positioning us to support the next wave of advanced therapy developers.”

The project will be led by Landmark Bio and incorporate cutting-edge technologies developed in collaboration through a subaward with the Massachusetts Institute of Technology (MIT). Work will include development and evaluation of intensified upstream production approaches, new capture and purification strategies, advanced analytical methods suited to small and heterogeneous particles, and the process modeling and control frameworks needed to operate an end-to-end continuous manufacturing platform. The program will proceed in two phases. Phase 1 focuses on process and analytical development and early integration work. Phase 2 advances pilot-scale implementation, including unit operation integration, process controls, and modeling to demonstrate a connected manufacturing workflow at pilot scale.

Landmark Bio expects the capabilities developed through this program to further strengthen its position as a leading-edge advanced therapies development and manufacturing partner supporting emerging modalities. The company will apply insights and technologies generated through this initiative to support partners pursuing extracellular vesicle programs and related next-generation therapeutic platforms where scalable manufacturing and robust analytical measurement are critical to advancing programs into the clinic and, ultimately, expanding patient access.

About Landmark Bio

Landmark Bio, an Artis BioSolutions company, provides integrated capabilities to support the development and scalable manufacturing of advanced therapies and emerging biotechnologies. Operating from its facility in Watertown, Massachusetts, the company combines process development, advanced analytics, and GMP manufacturing to help biotechnology and pharmaceutical partners translate breakthrough science into clinical and commercial reality. Learn more at: landmarkbio.com.

About Artis BioSolutions

Artis BioSolutions is a San Diego–based advanced therapies platform focused on developing and scaling the technologies, infrastructure, and capabilities required to enable next-generation medicines. The company combines proprietary and enabling technologies with specialized expertise across development and manufacturing to support biotechnology and pharmaceutical innovators advancing emerging therapeutic modalities. Learn more at artisbiosolutions.com.

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Award will expand Landmark Bio's capabilities in advanced manufacturing, analytics, and process control for biotech and pharma partners