SPRING HOUSE, PA and WATERTOWN, MA — ChromaTan Inc. and Landmark Bio PBLLC have been awarded a grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to support the development of an intensified manufacturing process for recombinant adeno-associated virus (AAV) vectors. This project is part of NIIMBL’s Viral Vector Manufacturing and Analytics Program and aims to address challenges in gene therapy production.
The grant will enable the two organizations to create an accessible, cost-effective manufacturing platform for AAV-based gene therapy vectors, aiming to improve scalability and efficiency. The collaboration brings together ChromaTan’s BioRMB™ technology and Kascade instrumentation with Landmark Bio’s specialized expertise in viral vector process development and GMP manufacturing.
“We are excited to collaborate with Landmark Bio, showcasing their capabilities together with ChromaTan’s BioRMB as a next-generation purification platform for gene therapy products,” said Oleg Shinkazh, CEO of ChromaTan. “This grant will enable development of our advanced manufacturing technology for multiple AAV serotypes, evaluation of their key process variables as well as manufacturability. Being able to share our findings not just with our partner but also with the broader NIIMBL community is incredibly gratifying.”
The effort also looks to reduce production costs and enhance efficiency in AAV manufacturing. “We believe this technology has the potential to reduce resin costs and improve step recoveries, increasing capacity while lowering the cost of goods and making these groundbreaking treatments more accessible to patients,” said Gregg Nyberg, Ph.D., chief technology officer of Landmark Bio. “Landmark is eager to integrate continuous chromatography into our Postmark™ AAV manufacturing platform.”
NIIMBL Senior Technology Fellow, Sandeep Kedia, highlighted the significance of the project, stating, “This project exemplifies NIIMBL’s commitment to identifying, investing in, and advancing high-potential member technologies through collaboration and partnership. By fostering innovation, we are strengthening manufacturing capabilities for emerging biopharmaceutical products. We look forward to the continued advancements in AAV vector production and their impact on the field.”
NIIMBL, part of the Manufacturing USA® network, focuses on accelerating biopharmaceutical innovation, improving manufacturing efficiency, and training a skilled workforce in the field. Through grants like this, NIIMBL advances U.S. competitiveness and supports innovation within the biopharmaceutical industry.
This project received financial assistance from the U.S. Department of Commerce, NIST, under award 70NANB21H086.
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