Manufacturing
The Colorado Laboratory & Innovative Manufacturing Building (CLIMB)
In October 2023, Umoja opened a company-owned, state-of-the-art lentiviral vector development and manufacturing facility called the CLIMB, in Louisville, Colorado. The CLIMB is a 146,000 square-foot, commercial-ready facility, capable of end-to-end manufacturing. The manufacturing facility is co-located with our laboratories to allow for industry-leading collaboration and speed in innovation. The CLIMB meets all Current Good Manufacturing Practice (CGMP) regulations, and as of 2024, is fully operational, generating CGMP-quality drug material.
Umoja is the only in vivo CAR T cell company that has invested in in-house manufacturing.
In-House Development + Manufacturing
Uniting novel drug development and manufacturing is key to who Umoja is, hoping to ensure our treatment can be made more widely accessible. By bringing development and manufacturing in house, we are able to continuously improve our manufacturing platform while increasing the quality of our lentiviral vector product. Additionally, in-house development and manufacturing allows Umoja to de-risk the supply chain while providing flexibility and adaptability over our lentiviral production for in vivo therapy. Our suspension-based process provides for fast first-in-human (FIH) studies and expansion to large-scale commercial production. Transient transfection can be used in the process, with the stable producer cell line technology also providing for enhanced scalability and strategic partnering opportunities with large-scale vector production.
